BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROAUTOCAT 2 WAVE

    MDR report key: 3837733 · Received March 5, 2014

    Report

    Report Number
    1219856-2014-00056
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 18, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED DURING A MED FLIGHT TRANSPORT. WHEN THE CREW ARRIVED AT THE SITE TO PICK UP THE PT, THEY RECEIVED AN ALARM FOR "LOW BATTERY FOR STATIC RAM, CALL SERVICE." AT THE TIME THEY PLUGGED THE INTRA-AORTIC BALLOON PUMP (IABP) INTO THE WALL. THEY POWERED DOWN AND REBOOTED. THE IABP SEEMED TO RUN FINE AFTER THAT. THEY TRANSPORTED THE PT USING THE POWER FROM THE AMBULANCE. THERE WERE NO ISSUES DURING TRANSPORT. AT THE ARRIVING FACILITY, PRIOR TO TRANSITION, THE SCREW ENCOUNTERED THE FOLLOWING ISSUE: 20 MINUTE WARNING WENT OFF, THE IABP SCREEN FLASHED TO WHITE AND SUBSEQUENTLY REBOOTED TWICE IN A ROW. AT A RESULT, THE PT WAS TRANSITIONED TO RECEIVING FACILITY IABP. THE IABP WAS RETURNED TO KBED (AN AREA THAT MED FLIGHTS THEY LEAVE THEIR EQUIPMENT TO BE CHECKED OUT), TAGGED AND PLACED OUT OF DEVICE. THIS EVENT DID NOT OCCUR UNTIL THEY WERE ALREADY IN POSITION AT THE RECEIVING SITE AND WERE IMMEDIATELY ABLE TO TRANSFER THE PT TO THE RECEIVING INSTITUTION IABP. THE FIELD SERVICE REP (FSR) RECEIVED A SERVICE CALL FROM CUSTOMER AND WAS SCHEDULED TO GO IN TO SERVICE THE UNIT ON (B)(6) 2014. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. AN UPDATE RECEIVED ON (B)(6) 2014 FROM THE SALES REP STATED THAT THE DELAY OR INTERRUPTION IN THERAPY WAS ONLY A MINUTE OR TWO BECAUSE THE IABP DIDN'T FAIL THE FIRST TIME UNTIL THEY PLUGGED INTO THE WALL AND GOT THE ALARM SO THEY HAD POWER. THE SECOND TIME IT FAILED WHEN THEY WERE ALREADY ON SITE AND ABOUT TO HOOK UP TO RECEIVING IABP. NO STRIPS WERE GENERATED, THERAPY WAS FINISHED. AFTER SPEAKING WITH THE EQUIPMENT MANAGER THE PT WAS FOUND TO HAVE 80% LMA (LEFT MAIN ARTERY), 100% LAD (LEFT ANTERIOR DESCENDING) AND 100% RCA (RIGHT CORONARY ARTERY). IABP PLACED PT WAS TRANSPORTED TO HOSPITAL WITHOUT INCIDENT OR CHANGE IN CONDITION. PER THE FIELD SERVICE REPORT: SYMP - LOW STATIC RAM AND 20 MINUTES LEFT ON BATTERY MESSAGES DURING A TRANSPORT OF A PT WAS CONFIRMED. FINDINGS/ACTION TAKEN: ALL VOLTAGES CHECK WITHIN SPECIFICATION. UNIT ALARMED WITH "20 MINUTES LEFT ON BATTERY" AND MESSAGE 20 MINUTES INTO BATTERY LOAD TEST. STARTING DC VOLTAGE WAS 12.2V AND UNIT HAD BEEN CHARGING OVERNIGHT. UNIT ALARMED 10 MINUTES, THEN 5 MINUTES LEFT ON BATTERY AND THEN SHUT OFF; ONLY LASTED 40 MINUTES ON BATTERY. REPLACED AC POWER CORD AND MEASURED ALL VOLTAGES WITHIN SPECIFICATION, CHARGING VOLTAGE 13.1V. REPLACED BATTERY WORN DISPLAY CABLE. UNIT PASSED FUNCTIONAL CHECKOUT. THE PUMP IS BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131586 AEROAUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRA-AORTIC BALLOON