MAQUET CARDIOHELP
Maquet Cardiopulmonary AG · Model CARDIOHELP-i · UDI-DI 04058863074863
Description
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 for periods appropriate to cardiopulmonary bypass (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).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-09 | Maquet Cardiopulmonary Gmbh | Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting ca |
| 2025-04-30 | Maquet Cardiopulmonary Ag | HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. |
| 2024-10-18 | LivaNova Deutschland GmbH | Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but |
| 2024-04-15 | Maquet Medical Systems USA | The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels. |
| 2023-12-28 | Maquet Medical Systems USA | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the |
| 2023-11-14 | Maquet Medical Systems USA | CARDIOHELP-i System was not properly tested to measure leakage current |
| 2023-11-13 | Maquet Medical Systems USA | Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of e |
| 2023-11-06 | Maquet Medical Systems USA | Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor |
| 2023-10-12 | Maquet Medical Systems USA | It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from th |
| 2023-10-10 | Maquet Medical Systems USA | Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potentia |
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