Heat-Exchanger, Cardiopulmonary Bypass
FDA adverse event reports and recall history for heat-exchanger, cardiopulmonary bypass (product code DTR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 858
- Deaths
- 6
- Injuries
- 91
- Malfunctions
- 705
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-05-26Open, ClassifiedPending
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
- 2015-12-02TerminatedEquipment maintenance
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
The products have been found to intermittently exhibit a seal failure during use.
- 2014-10-31TerminatedDevice Design
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity
Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line
- 2014-10-31TerminatedDevice Design
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
- 2014-10-31TerminatedDevice Design
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line
- 2014-03-10TerminatedDevice Design
MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.
- 2011-04-08TerminatedOther
Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.
User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
- 2010-09-29TerminatedEquipment maintenance
Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375
Medical device vent port may be occluded and prevent delivery of priming fluid.
- 2010-09-29TerminatedEquipment maintenance
Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720
Medical device vent port may be occluded and prevent delivery of priming fluid.
- 2010-09-29TerminatedEquipment maintenance
Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501
Medical device vent port may be occluded and prevent delivery of priming fluid.
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