Device product
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Z-2149-2012
Product summary
- Event
- Event 62563
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13
- Official record key
device-enforcement:Z-2149-2012
Official wording
Reason: On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a due to a complaint received regarding a rotor of the PP-04a pump that stopped during a therapeutic plasma exchange treatment causing interruption of flow of both the plasma discard line and replacement fruit line.
Code information: D11003544 through D11003552 D11003556 through D11003558
Distribution pattern: Natonwide Distribution
Derived failure modes
-
Unknown
On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a due to a complaint received regarding a rotor of the PP-04a pump that stopped during a therapeutic plasma exchange treatment causing interruption of flow of both the plasma discard line and replacement fruit line.