AUTOMATED IMPELLA CONTROLLER
Report
- Report Number
- 1220648-2024-10584
- Event Type
- Malfunction
- Date Received
- April 30, 2024
- Date of Event
- April 14, 2024
- Report Date
- June 13, 2024
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502011814
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE IMPELLA DEVICE WAS RETURNED AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.
THE INVESTIGATION FOR THE REPORTED CONSOLE (AIC) SELF CHECK ERROR HAS BEEN COMPLETED. THE CONSOLE WAS RETURNED FOR EVALUATION. DURING TESTING, THE REPORTED FAILURE MODE WAS REPRODUCED UPON TURNING ON THE CONSOLE. THE CABLE BETWEEN PUD AND THE 4-IN-1 WAS NOT FULLY SEATED AT THE 4-IN-1 SIDE. DATA LOGS WERE REVIEWED FINDIND THERE WAS A COMMUNICATION ISSUE WITH THE PUD DURING BOOT-UP, SO THE CONSOLE WAS REBOOTED AUTOMATICALLY. AFTER REBOOT, SINCE THE COMMUNICATION ISSUE WITH THE PUD WAS PERSISTENT, THE BOOT-UP PROCESS RESULTED IN A ¿SYSTEM SELF CHECK FAILED¿ SCREEN PER THE LOG ¿POST: SYSCALL10 CHECKFIRMWARE FAILED¿. THIS CONFIRMS THE REPORTED FAILURE MODE. THE ROOT CAUSE FOR THE SYSTEM SELF CHECK FAILURE WAS A LOOSE CABLE CONNECTION AT THE 4-IN-1 CONNECTOR. D4-UPDATED MODEL NUMBER
THE ABIOMED CLINICAL REPRESENTATIVE BROUGHT AN AUTOMATED IMPELLA CONTROLLER (AIC) TO THE USER FACILITY. UPON STARTUP, THE AIC DISPLAYED A "SELF-CHECK ERROR". THE AIC WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176174 | AUTOMATED IMPELLA CONTROLLER | CONTROL,, PUMP SPEED, CARDIOPULMONARY BYPASS | OZD | ABIOMED, INC. | AUTOMATED IMPELLA CONTROLLER | 1791478 | 00813502011814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Unknown |