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The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and requlates blood temperature. The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician. The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 5 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician. The membrane oxygenator QUADROX-iD Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates the blood temperature. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The QUADROX-i Small Adult / Adult and QUADROX-iD Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter (only available for QUADROX-I Small Adult / Adult). They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature. The integrated arterial filter is intended to filter out air bubbles and particles larger than 40µm. It is used for removing gaseous embolisms and aggregates from blood components from the arterial blood during extracorporeal circulation. It is a screen filter with pre-post-de-airing mechanic.

The Antegrade Cardioplegia Cannula acts as an infusion cannula for cardioplegic solutions. The cardioplegic solution is perfused via the aortic root into the coronaries. Furthermore, the Antegrade Cardioplegia Cannula can be used for left ventricular relaxation and aortic arch de-airing during cardiopulmonary bypass. The maximum duration of use is 6 hours.

The Antegrade Cardioplegia Cannula (N-Type) by MAQUET is used to administer cardioplegia solution into the heart in operative procedures where cardiopulmonary bypass is utilized. The cardioplegia solution causes asystole so that the operative procedure can be performed on a still heart. The Antegrade Cardioplegia Cannula (N-Type) is inserted into the aortic root through a purse-string suture towards the aortic cross clamp. This method allows the cardioplegia solution to flow into the coronary arteries, which is known as antegrade delivery.

The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation, in cardiopulmonary bypass operations on pediatric patients for up to 6 hours. The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating are developed for surgical procedures requiring cardiopulmonary bypass for pediatric patients. They are used as a blood buffer in the extracorporeal circuit and are used as a collecting and defoaming device for sucked blood. The device is supplied sterile and non-pryogenic.

The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

The CARDIOHELP System is a compact perfusion system consisting of the following components: - the CARDIOHELP-i drives suitable disposables using an integrated pump, controls and monitors the extracorporeal circulation and can communicate with other devices - . the CARDIOHELP Emergency Drive is used in emergencies to manually drive the disposable if the CARDIOHELP-i fails - different accessories: . - flow/bubble sensor O - o level sensor including level sensor pad - venous probe for blood gas monitoring and measurement of venous temperature o - external sensors for temperature and pressure O - different holders o - connection cables ಂ - . various disposables, that can be driven by CARDIOHELP-i, including the previously cleared HLS/HIT tubing sets and the Quadrox-iR disposables (part of the predicate CARDIOHELP System (K102726).

The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

The only modification consists of adding a reusable stainless steel holding clamp as an interim protective safeguard / corrective action to prevent the inlet and/or outlet connector from disconnection. The holding clamp is applied by the perfusionist prior to use. The holding clamp is applicable to all QUADROX-iR oxygenators which are subject to this submission.

The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours. The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours. The membrane oxygenator QUADROX-i Pediatric is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Pediatric (HMO 31000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um. The utilization period of this device is restricted to six hours. The membrane oxygenator QUADROX-i Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 1.5 Vmin and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Neonatal (HMO 11000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um. The utilization period of this device is restricted to six hours. The QUADROX-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours. The Diffusion Membrane Oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The oxygenator is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dicxide and regulates the blood temperature. The utilization period for this device is restricted to six hours.

The only modification consists of adding a reusable stainless steel holding clamp as an interim protective safeguard / corrective action to prevent the inlet and/or outlet connector from disconnection. The holding clamp is applied by the perfusionist prior to use. The holding clamp is applicable to all QUADROX-i / -iD oxygenators which are subject to this submission.

The HLS Cannula from MAQUET is intended for use by trained physicians only. The HLS Cannula may be utilized to cannulate suitable vessels to provide circulatory perfusion of organs and vessels by forming a connection with the extracorporeal circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.

The HLS Cannula from MAQUET is a wire-reinforced, thin-wall cannula made of polyurethane. The transparent proximal section has no reinforcement and can be clamped. Each cannula is supplied with a pre-mounted 3/8" connector and an introducer that allows a guide wire up to 0.038" to be inserted. The cannula is available with an optional percutaneous insertion kit for the Seldinger technique and optional BIOLINE or SOFTLINE Coating. The HLS Cannula comes in a range of sizes and lengths. The HLS Cannula is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The insertion kit from MAQUET comprises various components which permit access to the vessels. One insertion kit is available for the arterial cannula (PIK 100) with a length of 100 cm and one for the venous cannula (PIK 150) with a length of 150 cm. Additionally as accessories to the percutaneous insertion kit, there are two sets with further dilatators available. One set with larger dual step dilatators (18 / 20, 20 / 22, 22 / 24 Fr) for a better vessel dilation in the cases where cannulae are used bigger than 23 Fr. One set contains a smaller dilatator (8 / 10 Fr), dedicated for the insertion of the smaller cannulae like 13 Fr. As further accessories are separately guidewire sets available. These guidewire sets consist of five separately packed quidewires (lengths 100 or 150 cm) which are the identic articles as used in the Percutaneous Insertion Kit itself.

The HCU 40 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The Heater-Cooler Unit HCU 40 is used to supply temperature-controlled water to regulate the patient temperature during extracorporeal circulation (ECC). Further application areas are warming and/or cooling therapies. The device can also be used to control the temperature of a cardioplegia solution. Therefore the Heater-Cooler Unit HCU 40 contains two independent water circuits. One circuit (main circuit) can be connected to the blood heat exchanger (part of the oxygenator) and/or to the warming/cooling blanket. The other circuit (cardioplegia circuit) can be connected to the cardioplegia heat exchanger. The use of an UV treatment does significantly enhance the water quality between the water change intervals. The heat exchange with the patient and the cardioplegia fluid occurs when the water passes the heat exchangers and/or the blanket. The water temperature of the main and the cardioplegia circuit can be regulated independently from each other.

The MAQUET Hemoconcentrators are used to remove excess fluid from the blood or to concentrate highly diluted blood solutions. They are only intended for use for blood concentration during and/or following cardiopulmonary bypass procedures. The maximum duration of use is 6 hours. The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator.

BC 60 plus, BC 140 plus Hemoconcentrators are used to remove excess fluid from the blood during and/or following cardiopulmonary bypass procedures. Hemoconcentrators are ready for use after they have been filled and vented as the membrane contains no stabilizers. The type of Hemoconcentrator used is determined by the protocol used.