EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM
Report
- Report Number
- 3004582654-2019-00038
- Event Type
- Malfunction
- Date Received
- May 9, 2019
- Date of Event
- April 14, 2019
- Report Date
- May 9, 2019
- Manufacturer
- BERLIN HEART GMBH
- Product Code
- DSQ
- UDI-DI
- 04260090040157
- PMA / PMN Number
- P160035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH(MANUFACTURER). A TYPO WAS MADE IN THE RESULTS CODE. INSTEAD OF 3252, IT SHOULD BE 3253 (FRICTION PROBLEM).
EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH(MANUFACTURER). THE EXCOR BLOOD PUMP, S/N (B)(4), WAS IN USE BY THE PATIENT FROM (B)(6) 2018 UNTIL (B)(6) 2019 (116 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE BLOOD PUMP IS DESIGNED WITH A TRIPLE LAYER MEMBRANE SEPARATING THE AIR CHAMBER FROM BLOOD CHAMBER FOR SAFETY REASONS. THE ENTIRE MEMBRANE CONSISTS OF AN AIR-SIDE LAYER, A MIDDLE LAYER AND A BLOOD-SIDE LAYER. IN CASE OF DISRUPTION IN ONE OF THE TRIPLE LAYERS, THERE ARE TWO MORE LAYERS THAT WILL MAINTAIN THE INTEGRITY OF THE AIR AND BLOOD CHAMBERS. INITIAL INSPECTION OF THE RETURNED PUMP INDICATED A DEFECTIVE AIR-SIDE LAYER. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS AVAILABLE.
EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE AFFECTED BLOOD PUMP WAS RETURNED TO BERLIN HEART FOR ANALYSIS FOLLOWING THE EXCHANGE. THE CUSTOMER COMPLAINT CAN BE CONFIRMED. DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, AN AIR CUSHION WAS DETECTED BETWEEN THE MEMBRANE LAYERS. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. AN AIR CUSHION WAS DETECTED BETWEEN THE MIDDLE AND BLOOD-SIDE LAYERS. PARTICLES COULD BE SEEN BETWEEN THE MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED.A LEAK WAS NOTED IN THE AIR-SIDE LAYER AT THE EDGE REGION. TWO LEAKS WERE DETECTED IN THE MIDDLE LAYER, LOCATED CLOSE TO THE CENTER. FURTHERMORE, GRAPHITE AGGLOMERATES WERE DETECTED BETWEEN THE MEMBRANE INTERSTICES. THE BLOOD-SIDE LAYER WAS FOUND TO BE INTACT. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE INDIVIDUAL LAYERS AT ALL THE FIXED LOCATIONS AND ALSO AT THE REGION OF THE LEAKS WAS RE-MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CAUSE OF THE DEFECT WAS MOST LIKELY THE GRAPHITE PARTICLES THAT FORMED DUE TO AN ABRASION BETWEEN THE LAYERS. THIS CAUSED INCREASED FRICTION AT POINTS, WHICH FINALLY LED TO THE DEFECT IN THE AIR-SIDE AND MIDDLE LAYERS OF THE TRIPLE-LAYER MEMBRANE. AS A RESULT OF THIS DEFECT, AIR GOT IN AND FORMED AN AIR CUSHION IN THE MEMBRANE INTERSTICES, CAUSING THE REDUCED PUMP PERFORMANCE (INCOMPLETE FILLING AND EMPTYING).
WE WERE CONTACTED BY THE (B)(6) DISTRIBUTOR TO REPORT A SUSPECTED MEMBRANE DEFECT IN THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE BLOOD PUMP WAS EXCHANGED BY TRAINED PROFESSIONALS AT THE CLINIC. THE CLINIC PROVIDED A VIDEO OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS BY TRAINED PERSONNEL AT THE CLINIC. THE PATIENT WAS NOT AFFECTED BY THE INCIDENT AND IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387745 | EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM | VENTRICULAR ASSIST DEVICE | DSQ | BERLIN HEART GMBH | P15P-001 | 04260090040157 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR |