FDA Adverse Event
Malfunction
Summary report: N
PURGE CASSETTE GEN 2, STERILE, NON QSK
MDR report key: 23933695
·
Received December 31, 2025
Report
- Report Number
- 1220648-2025-49572
- Event Type
- Malfunction
- Date Received
- December 31, 2025
- Date of Event
- September 12, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- DYB
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A4 IS UNKNOWN. THE PUMP WAS NOT RETURNED FOR INVESTIGATION. THE DATA LOG WAS NOT PROVIDED. THE CAUSE OF THE PURGE PRESSURE LOW ISSUE WAS NOT DETERMINED WITHOUT RETURNED PRODUCT AND SUFFICIENT CLINICAL DETAILS.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP OBSERVED LOW PURGE PRESSURE SO THE PURGE CASSETTE WAS REPLACED. LATER, THE PATIENT WAS SUCCESSFULLY WEANED FROM THE PUMP AND SURVIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2570696 | PURGE CASSETTE GEN 2, STERILE, NON QSK | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | DYB | ABIOMED, INC. | PURGE CASSETTE GEN 2, STERILE, NON QSK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male |