BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROAUTOCAT 2

    MDR report key: 1842076 · Received August 27, 2010

    Report

    Report Number
    1219856-2010-00583
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCOUNT WAS EXPERIENCING "PURGE FAILURE" ALARMS EVERY TIME THEY TRIED TO PUMP THE PATIENT. THEY WERE TRYING TO TRANSPORT PATIENT FROM HOSPITAL; PATIENT HAD DATASCOPE INTRA-AORTIC BALLOON (IAB) IN PLACE. THEY CONNECTED IAB TO THE AUTOCAT 2 TUBING USING A 40CC IAB ARROW CONNECTOR. AFTER THEY RECEIVED THE FIRST "PURGE FAILURE" ALARM, THEY CHECKED THE IAB CONNECTOR. THEY RECONNECTED IT AND STILL GOT A "PURGE FAILURE" ALARM. THEY CHANGED THE CONNECTOR OUT FOR A SECOND IAB CONNECTOR AND STILL GOT THE ALARM. THEY HAD A GOOD ECG AND ARTERIAL PRESSURE (AP) WAVEFORM ON THE SCREEN; PUMP WAS IN AUTO PILOT. THEY CHECKED THE HELIUM TANK. WHEN THEY CONTINUED TO GET THE "PURGE FAILURE" ALARMS, THEY CALLED THE HOT LINE. IAB WORKED APPROPRIATELY WITH THE DATASCOPE PUMP. THEY VERIFIED THEY HAD CONNECTOR CONNECTED SECURELY TO PUMP, THAT O-RINGS WERE NOT DAMAGED AND THAT HELIUM TANK WAS TURNED ON. AGAIN, THEY HAD A GOOD ECG AND AP SIGNAL ON PUMP. IT WAS EXPLAINED THAT THE "PURGE FAILURE" ALARM USUALLY IS DUE TO EITHER A BAD IAB CONNECTION, NO HELIUM TO FILL THE IAB, OR NO TRIGGER SOUNDS. THEY SWITCHED TO OPERATOR MODE AND USED AP TRIGGER AND HAD SAME RESULTS. THEY POWERED DOWN AND RESTARTED PUMP. WHEN THEY TRIED TO PUMP, THEY AGAIN GOT A "PURGE FAILURE" ALARM. THEY THEN DID A LEAK TEST ON PUMP. WHEN THEY TRIED TO PUMP DURING THE LEAK TEST, THEY CONTINUED TO GET A "PURGE FAILURE" ALARM. AT THIS POINT, THEY WERE ADVISED TO OBTAIN ANOTHER PUMP OR USE THE DATASCOPE PUMP FOR TRANSPORT. THEY WERE INSTRUCTED TO HAVE THE PUMP CHECKED AND FIELD SERVICE WOULD BE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROAUTOCAT 2 INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DATASCOPE IABP| DATASCOPE IAP