LIFESPARC SYSTEM
Report
- Report Number
- 2531527-2021-00032
- Event Type
- Malfunction
- Date Received
- September 2, 2021
- Date of Event
- August 5, 2021
- Report Date
- September 2, 2021
- Manufacturer
- CARDIACASSIST INC.
- Product Code
- KFM
- PMA / PMN Number
- K183623
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H10: DURING INVESTIGATION, THE DEVICE OPERATED FOR A TOTAL OF 31 DAYS WITH NO ERRORS. THE DATA LOG WAS REVIEWED SHOWING THAT THE DEVICE WAS POWERED ON DURING (B)(6) 2021. THE DATA LOG WAS FOUND TO CONTAIN A POWER ON WITHOUT A PRIOR POWER OFF AT (B)(6) 2021 AND OPERATING HOURS WERE NOT UPDATED. THIS IS CONSISTENT WITH A WATCHDOG TIMEOUT OR OTHER FAILURE OF THE COMPUTER BOARD OR A SUDDEN LOSS OF POWER. THERE WERE NO BUTTON PRESSES OR ALARMS INITIATED IN PROXIMITY TO THE EVENT. VISUAL INSPECTION OF WATCHDOG HARDWARE COMPONENTS REVEALED MULTIPLE INSTANCES OF SOLDER SPLASH AND SOLDER BALLS WERE FOUND, ALONG WITH FOREIGN OBJECT DEBRIS WHICH APPEARED TO BE METALLIC. THIS WAS LOCATED IN MULTIPLE AREAS ON THE MAIN BOARD. THE CHASSIS SUBASSEMBLY WILL BE REPLACED. DHR REVIEW HAS NOT POINTED OUT ANY DEVIATIONS OR NON-CONFORMITIES POSSIBLY RELEVANT TO OCCURRED ISSUE AND NO FURTHER SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR THIS UNIT SINCE ITS INSTALLATION IN (B)(6) 2021. BASED ON THE INVESTIGATION RESULTS, SOLDER AND METALLIC DEBRIS PRESENTED IN MULTIPLE AREAS OF THE BOARD COULD HAVE CONTRIBUTED TO THE REPORTED INTERMITTENT ISSUE WHICH DID NOT OCCURRED DURING THE EVALUATION.
H.10. THE INVOLVED COMPONENT IS MANUFACTURED BY EXTERNAL SUPPLIER (TRANSONIC). CONSEQUENTLY SCAR 220003 HAS BEEN ISSUED TO THE INVOLVED SUPPLIER IN ORDER TO TAKE APPROPRIATE CORRECTIVE ACTIONS TO PREVENT FURTHER OCCURRENCES. NO OTHER SPECIFIC ACTION HAS BEEN DEEMED NECESSARY. LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT. IF ANY ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
SEE INITIAL REPORT.
SEE INITIAL REPORT.
THERE WAS NO PATIENT INVOLVEMENT. CARDIACASSIST INC. MANUFACTURES THE LIFESPARC SYSTEM .THE INCIDENT OCCURRED IN WASHINGTON, DISTRICT OF COLUMBIA. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER SITE FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
LIVANOVA RECEIVED REPORT THAT A PATIENT WAS PLACED ON VA ECMO ON (B)(6) 2021. ON (B)(6) 2021, TEAM HAD CHANGED OUT ORIGINAL PUMP HEAD FOR CLOT BURDEN. REPORTEDLY, THE CLOT BURDEN WAS EXPECTED SINCE THE PATIENT IS COAGULOPATHIC. PUMP WAS SUCCESSFULLY CHANGED OUT AS WELL AS THE CONTROLLER UNIT FOR NEW CIRCUIT. 5 HOURS POST INITIATION OF NEW CIRCUIT AND NEW LIFESPARC CONTROLLER UNIT, A CONTINUOUS HIGH PITCHED ALARM WAS HEARD, PATIENT BEGAN TO DROP PRESSURE. THE NURSE ENTERED THE ROOM AND THE SYSTEM/CIRCUIT HAD POWERED DOWN COMPLETELY. IT IS NOT CLEAR IF THE PUMP WAS STILL RUNNING WHILE UNIT WAS ALARMING AND PREVIOUS TO DEVICE SHUTDOWN. REPORTEDLY, THE PUMP HAD STOPPED FOR AROUND 60 SECONDS. ANOTHER CONTROLLER UNIT WAS USED AND THE SUPPORT COULD BE CONTINUED WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1310236 | LIFESPARC SYSTEM | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | CARDIACASSIST INC. | 5900-0001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |