Heat-exchanger, Cardiopulmonary Bypass

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass

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.

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. deli

The products have been found to intermittently exhibit a seal failure during use.

Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass

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

Terumo Cardioplegia Delivery Set-

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

Terumo Custom Cardioplegia Delivery Sets

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

MAQUET PLEGIOX Cardioplegia Heat Exchanger

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.

Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature

User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.

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.

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.

Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501

Medical device vent port may be occluded and prevent delivery of priming fluid.