Device product
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Z-2832-2016
Product summary
- Event
- Event 74991
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-2832-2016
Official wording
Reason: The seal between the balloon and the housing may leak.
Code information: Lot # 014648 USE BY: 09/01/2018
Distribution pattern: US Distribution to states of: LA, MI, NY, OH, OR & TX.
Derived failure modes
-
Unknown
The seal between the balloon and the housing may leak.