AC3 OPTIMUS IABP NA/EMEA
Report
- Report Number
- 3010532612-2023-00142
- Event Type
- Malfunction
- Date Received
- March 2, 2023
- Date of Event
- February 7, 2023
- Report Date
- February 7, 2023
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DSP
- UDI-DI
- 10801902172065
- PMA / PMN Number
- K162820
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#(B)(4). N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
QN#(B)(4). RETURNED FOR INVESTIGATION WAS A PCS ASSEMBLY (P/N: 96-3006-001, S/N: (B)(6). VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE PCS ASSEMBLY WAS INSTALLED INTO A KNOWN GOOD AC3 FOR FUNCTIONAL TESTING. THE PUMP WAS POWERED ON, AND PUMPING WAS INITIATED. THE PUMP ALARMED "POSSIBLE HELIUM LOSS 3". THE PUMP FAILED PATIENT SIDE LEAK TESTING. THE LEAK WAS DETECTED FROM THE DRAIN PORT. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED. DRIED BLOOD WAS NOTED INSIDE THE DRAIN VALVE (V4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE SERIAL NUMBER/LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE RISK IS ACCEPTABLE. THIS COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS. THE REPORTED COMPLAINT OF HELIUM LOSS ALARM IS CONFIRMED. A LEAK WAS DETECTED FROM THE DRAIN PORT AND CAUSED THE PUMP TO TRIGGER "POSSIBLE HELIUM LOSS 3". DRIED BLOOD WAS NOTED INSIDE THE DRAIN VALVE DURING INSPECTION OF THE INTERNAL HARDWARE WHICH IS THE SUSPECTED CAUSE OF THE LEAK. 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 DRAIN VALVE LEAK CAUSED BY DRIED BLOOD. THE ROOT CAUSE OF HOW THE BLOOD ENTERED THE PCS ASSEMBLY IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.
REPORTED AS "HELIUM LOSS #2 AND #3 OCCURRED ON THE PUMP". AS REPORTED BY THE FIELD SERVICE REPRESENTATIVE, "RECEIVED HELIUM LOSS ALARMS ALMOST IMMEDIATELY. REPLACED PCS. FOUND BATTERY BRACKET DETACHED. REPLACED BRACKET. PERFORMED FUNCTIONAL CHECK OUT. UNIT CHECKS OK". MULTIPLE ATTEMPTS WERE MADE TO THE CUSTOMER REGARDING IF THE ISSUE WAS ENCOUNTERED DURING USE ON PATIENT, HOW WAS THE ISSUE RESOLVED, WAS MEDICAL INTERVENTION REQUIRED, AND WHAT THE CURRENT HEALTH CONDITION OF THE PATIENT IS. THE CUSTOMER DID NOT RETURN ANY REQUESTS FOR INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED ON THIS COMPLAINT, THE FILE WILL BE UPDATED.
REPORTED AS "HELIUM LOSS #2 AND #3 OCCURRED ON THE PUMP". AS REPORTED BY THE FIELD SERVICE REPRESENTATIVE, "RECEIVED HELIUM LOSS ALARMS ALMOST IMMEDIATELY. REPLACED PCS. FOUND BATTERY BRACKET DETACHED. REPLACED BRACKET. PERFORMED FUNCTIONAL CHECK OUT. UNIT CHECKS OK". MULTIPLE ATTEMPTS WERE MADE TO THE CUSTOMER REGARDING IF THE ISSUE WAS ENCOUNTERED DURING USE ON PATIENT, HOW WAS THE ISSUE RESOLVED, WAS MEDICAL INTERVENTION REQUIRED, AND WHAT THE CURRENT HEALTH CONDITION OF THE PATIENT IS. THE CUSTOMER DID NOT RETURN ANY REQUESTS FOR INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED ON THIS COMPLAINT, THE FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517194 | AC3 OPTIMUS IABP NA/EMEA | SYSTEM, BALLOON, INTRA-AORTIC | DSP | ARROW INTERNATIONAL LLC | IPN917285 | N/A | 10801902172065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |