BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 15341711 · Received September 1, 2022

    Report

    Report Number
    3010532612-2022-00343
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 5, 2022
    Report Date
    August 5, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902172065
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). RETURNED FOR INVESTIGATION WERE THE MARTEK POWER SUPPLY (P/N: 33-0063-001, S/N: (B)(6) ), THE AC3 FRONT-END BOARD (P/N: 33-1020-003, S/N: (B)(6) ), THE CPM BOARD WITH 3.11.00 FIRMWARE (P/N: 33-1000-003, S/N: (B)(6) ), AND THE FOS BOARD (P/N: 77-1200-001, S/N: (B)(6) ). VISUAL INSPECTION OF SAMPLES WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE CPM BOARD, FRONT-END BOARD AND THE FOS BOARD WERE INSTALLED INTO A KNOWN GOOD AC3 FOR FUNCTIONAL TESTING. THE PUMP WAS POWERED UP SUCCESSFULLY. THE FOS TESTER WAS INSERTED INTO FOS SLIDER ASSEMBLY. THE FOS WAS RECOGNIZED WITH A STATUS OK ALONG WITH AN AUDIBLE TONE. THE FOS BOARD WAS THEN TESTED WITH THE FOS TESTER, USING THE DIGITAL MANOMETER AND TYCOS GAGE TO DETERMINE IF THE FOS SENSOR WOULD COMMUNICATE AND DISPLAY THE PROPER PRESSURE READINGS ON THE IABP DISPLAY WHEN IN USE. THE SENSOR WAS SUBJECTED TO MULTIPLE PRESSURES (0, 50, 100, 150, 200 AND 250 MMHG). THE READINGS ON THE DIGITAL MANOMETER WERE COMPARED TO THE IABP DISPLAY READINGS AND THEY WERE WITHIN THE ACCEPTABLE TOLERANCES. THE STATIC RAM AND ALL VOLTAGES WERE WITHIN SPECIFICATION. PUMPING WAS INITIATED. MULTIPLE CLASS 1 ALARMS WERE PURPOSELY GENERATED, AND PIEZO ALARM (HIGH PITCH AUDIBLE TONE) WAS TRIGGERED EACH TIME. BPW, ECG, AND AP WAVEFORMS WAS MONITORED WHILE PUMPING FOR OVER 30 MINUTES AND NO ABNORMALLY WAS NOTED. THE PUMP WAS THEN LEFT TO RUN FOR OVER 2 HOURS AND NO ALARMS OR ERRORS.THE POWER SUPPLY WAS INSTALLED INTO A KNOWN GOOD AC3 FOR FUNCTIONAL TESTING. THE PUMP COULD NOT POWER-UP. THE POWER SUPPLY VOLTAGE CHECK WAS PERFORMED PER AC3 SERIES SERVICE MANUAL AND ALL OUTPUT VOLTAGES WERE NOT PRESENTED ALONG WITH BLANK SCREEN ON POWER-UP. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A NON-CONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THE ISSUE. THE REPORTED COMPLAINT OF " PUMP SHUT OFF COMPLETELY DURING TRANSPORT" IS CONFIRMED. DURING COMPLAINT INVESTIGATION OF THE POWER SUPPLY, NO VOLTAGE OUTPUTS WERE PRESENT DURING TESTING WHICH IS THE CAUSE OF THE REPORTED ISSUE. THE FRONT-END BOARD, CPM BOARD AND FOS BOARD PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS.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 NO OUTPUT VOLTAGES FROM THE POWER SUPPLY. THE ROOT CAUSE OF THE POWER SUPPLY VOLTAGE OUTPUT FAILURE IS UNDETERMINED. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS.A NON-CONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PUMP SHUT OFF COMPLETELY DURING TRANSPORT. IT WAS PLUGGED IN PRIOR TO TRANSPORT, BUT NOW AS THEY GO TO TURN IT BACK ON, THEY ARE JUST GETTING AN ALARM AND NO VISUAL ON THE SCREEN". ADDITIONAL INFORMATION RECEIVED STATED THAT "PUMP HAD TO BE SWAPPED OUT. NO MEDICAL INTERVENTION REQUIRED". PATIENT CONDITION REPORTED AS "STABLE - UNAFFECTED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PUMP SHUT OFF COMPLETELY DURING TRANSPORT. IT WAS PLUGGED IN PRIOR TO TRANSPORT, BUT NOW AS THEY GO TO TURN IT BACK ON, THEY ARE JUST GETTING AN ALARM AND NO VISUAL ON THE SCREEN". ADDITIONAL INFORMATION RECEIVED STATED THAT "PUMP HAD TO BE SWAPPED OUT. NO MEDICAL INTERVENTION REQUIRED". PATIENT CONDITION REPORTED AS "STABLE - UNAFFECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831518 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 NONE REPORTED| NONE REPORTED