AC3 OPTIMUS IABP NA/EMEA
Report
- Report Number
- 3010532612-2023-00275
- Event Type
- Malfunction
- Date Received
- May 19, 2023
- Date of Event
- May 1, 2023
- Report Date
- May 1, 2023
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DSP
- UDI-DI
- 10801902172065
- PMA / PMN Number
- K162820
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). RETURNED FOR INVESTIGATION WAS THE AC3 FOS BOARD (P/N: 77-1200-001 S/N: (B)(6)). THE SAMPLE WAS RETURNED IN AN FOS BOARD SHIPPING BOX CONTAINED WITHIN A BROWN CARDBOARD BOX. THE FOS BOARD WAS ENCLOSED IN AN ELECTROSTATIC PROTECTIVE BAG. VISUAL INSPECTION OF THE FOS BOARD WAS PERFORMED. A DRIED WHITE SUBSTANCE WHICH APPEARED TO BE DRIED SALINE WAS NOTED NEAR THE TOP OF THE PCB NEXT TO THE CAL KEY CONNECTOR. THE FOS CONNECTOR WAS NOTED TO BE INTACT AND PROPERLY POSITIONED IN ITS HOUSING. THE FOS BOARD WAS INSTALLED INTO A KNOWN GOOD AC3 FOR FUNCTIONAL TESTING. THE PUMP STARTED UP SUCCESSFULLY. THE FOS TESTER WAS INSERTED INTO FOS SLIDER ASSEMBLY. THE FOS WAS NOT RECOGNIZED WITH NO AUDIBLE TONE, BUT THE CAL KEY WAS RECOGNIZED. THE FOS STATUS WAS "NOT CONNECTED". THIS WAS REPEATED WITH A SECOND FOS TESTER WITH THE SAME RESULT. A PATIENT SIMULATOR WAS CONNECTED TO THE PUMP AND PUMPING WAS INITIATED. THE PUMP WAS LEFT TO RUN FOR APPROXIMATELY 30 MINUTES AND NO OTHER ALARMS OR ERRORS WERE NOTED. INSPECTION OF THE INTERNAL PCB WAS PERFORMED AND A DRIED SUBSTANCE THAT APPEARED TO BE DRIED SALINE WAS NOTED AT SEVERAL POINTS ON THE PCB. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLAINT OF "FOS WEAK SIGNAL" IS CONFIRMED. THE RETURNED FOS BOARD DID NOT RECOGNIZE THE FOS. INSPECTION OF THE INTERNAL PCB REVEALED A WHITE SUBSTANCE WHICH APPEARED CONSISTENT WITH DRIED SALINE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER , THE RECEIVED PRODUCT DID NOT MEET SPECIFICATIONS DURING THE COMPLAINT INVESTIGATION DUE TO THE UNRECOGNIZED FOS. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.
QN#(B)(4).
IT WAS REPORTED THAT WHEN THE PATIENT ARRIVED TO THE ICU FROM THE CATH LAB, THE PUMP ALARMED FOR FOS WEAK SIGNAL. THE STAFF REMOVED THE CAL KEY AND FIBER CONNECTION AND RECONNECTED THEM TO THE PUMP TWICE WITH NO IMPROVEMENT. THE PATIENT WAS IN NSR AND TIMING WAS APPROPRIATE. THE PUMP WAS THEN READING THE FIBEROPTIC PRESSURE AND NOT THE TRANSDUCER. THE STAFF POWERED DOWN THE PUMP AND RESTARTED. UPON RESTARTING, THE PUMP THEN READ THE FIBEROPTIC PRESSURE WITHOUT THE FIBER CONNECTED TO THE PUMP. AS A RESULT, THE PUMP WAS SWAPPED OUT FOR ANOTHER PUMP. AFTER SWAPPING OUT THE PUMP, THE FIBEROPTIC CATHETER WAS ABLE TO BE CALIBRATED AND WORKED FINE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
IT WAS REPORTED THAT WHEN THE PATIENT ARRIVED TO THE ICU FROM THE CATH LAB, THE PUMP ALARMED FOR FOS WEAK SIGNAL. THE STAFF REMOVED THE CAL KEY AND FIBER CONNECTION AND RECONNECTED THEM TO THE PUMP TWICE WITH NO IMPROVEMENT. THE PATIENT WAS IN NSR AND TIMING WAS APPROPRIATE. THE PUMP WAS THEN READING THE FIBEROPTIC PRESSURE AND NOT THE TRANSDUCER. THE STAFF POWERED DOWN THE PUMP AND RESTARTED. UPON RESTARTING, THE PUMP THEN READ THE FIBEROPTIC PRESSURE WITHOUT THE FIBER CONNECTED TO THE PUMP. AS A RESULT, THE PUMP WAS SWAPPED OUT FOR ANOTHER PUMP. AFTER SWAPPING OUT THE PUMP, THE FIBEROPTIC CATHETER WAS ABLE TO BE CALIBRATED AND WORKED FINE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622516 | AC3 OPTIMUS IABP NA/EMEA | SYSTEM, BALLOON, INTRA-AORTIC | DSP | ARROW INTERNATIONAL LLC | IPN917285 | N/A | 10801902172065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |