PURGE CASSETTE, STERILE, NON-QSK
Report
- Report Number
- 1220648-2025-46000
- Event Type
- Malfunction
- Date Received
- September 2, 2025
- Date of Event
- August 12, 2025
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B.5 ADDITIONAL INFORMATION WAS RECEIVED. D.3 MANUFACTURER NAME SHOULD NOT HAVE CONTAINED NUMBERS BEHIND IT ON THE INITIAL REPORT THAT WAS SUBMITTED. D.4 MODEL WAS ADDED AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. D.9 ADDED DEVICE WAS RETURNED AND THE DATE. THE INVESTIGATION HAS BEEN COMPLETED. PURGE CASSETTE SN(B)(6) WAS RETURNED FOR INVESTIGATION. PURGE LEAK - CASSETTE: NO VISUAL ABNORMALITIES WERE NOTED ON THE RETURNED CASSETTE. IT WAS FOUND TO BE LEAKING FROM THE PURGE DISC DURING THE PRIMING TEST. THE DATA LOG ALSO SHOWS PURGE LEAK PATTERN IN THE PURGE PRESSURE AND PURGE FLOW PARAMETERS WITH PURGE PRESSURE LOW ALARM, OCCURRING DURING CASE START. NO SIMILAR PURGE LEAK COMPLAINTS WERE REPORTED ON CONSOLE IC3493. THE CAUSE OF THE PURGE LEAK-CASSETTE ISSUE WAS A DAMAGED PURGE DISC DUE TO COMPONENT FAILURE. PURGE PRESSURE LOW: THE CAUSE OF THE PURGE PRESSURE LOW ISSUE WAS A DAMAGED PURGE DISC DUE TO COMPONENT FAILURE. A DEVICE HISTORY REVIEW WAS COMPLETED AND THE PURGE CASSETTE GEN1 SN(B)(6), LOT 1933622 PASSED ALL ENVIRONMENTAL QUALIFICATION TESTING INSPECTION CHECKS.
CORRECTED INFORMATION WAS PROVIDED IN H3 (DEVICE EVALUATED BY MANUFACTURER?). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED IN THE PREVIOUS REPORT. THE CAUSE OF THE PURGE LEAK-CASSETTE ISSUE WAS A DAMAGED PURGE DISC DUE TO COMPONENT FAILURE. THE CAUSE OF THE PURGE PRESSURE LOW ISSUE WAS A DAMAGED PURGE DISC DUE TO COMPONENT FAILURE.
THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
B.7 ADDITIONAL INFORMATION WAS ADDED THAT WAS INADVERTENTLY OMITTED ON THE INITIAL REPORT THAT WAS SUBMITTED. MEDICAL SAFETY REVIEWED THE EVENT. THE EVENT DESCRIBES PURGE CASSETTE LEAK RESULTING IN AN ALARM OF PURGE PRESSURE LOW. THE PURGE SYSTEM WAS SUCCESSFULLY REPLACED. THE PURGE CASSETTE HAD A MALFUNCTION AND DID NOT CONTRIBUTE TO THE DEMISE OUTCOME. THERE WAS LOW PURGE PRESSURE BUT THERE WAS NO INTERRUPTION OR COMPROMISED TO SUPPORT BECAUSE IT OCCURRED BEFORE IMPLANTATION OF THE IMPELLA CP. CONSERVATIVELY, THE DEATH WILL BE REPORTED AS THE IMPELLA CP WAS IN USE AT TIME OF EXPIRATION. WITHDRAWING CARE LED TO THE PATIENT'S DEMISE. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA CASSETTE DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE REPORT ON THE IMPELLA CP, WHICH IS ASSOCIATED WITH THE DEMISE OUTCOME.
ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT EXPIRED. THE DEATH WILL BE CAPTURED UNDER A SEPARATE REPORT FOR THE PUMP.
THE COMPLAINANT REPORTED THAT FOLLOWING IMPELLA CP IMPLANT, A PURGE PRESSURE TOO LOW MESSAGE APPEARED ON THE CONSOLE. TROUBLESHOOTING WAS PERFORMED AND A FLUID LEAK WAS IDENTIFIED FROM UNDER THE PURGE DISC. THE PURGE CASSETTE WAS REPLACED TO RESOLVE THE ISSUE. SUPPORT CONTINUED WITH THE SETUP FOLLOWING CASSETTE REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2865073 | PURGE CASSETTE, STERILE, NON-QSK | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | PURGE CASSETTE, STERILE, NON-QSK | 1937877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male |