BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2

    MDR report key: 2882981 · Received December 18, 2012

    Report

    Report Number
    1219856-2012-00365
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 22, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    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 EVENT INVOLVED A MALE PATIENT WHILE IN THE INTENSIVE CARE UNIT. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED SHEATHLESS VIA LEFT FEMORAL ARTERY WITH NO ISSUES NOTED. APPROXIMATELY 15 HOURS LATER THE PUMP ALARMED, STOPPED WORKING AND THE SCREEN FROZE. THE ALARM SHOWED THAT COUNTERPULSATION FAILED AND TIMING WAS LOST. THE PUMP WAS RESTARTED, BUT IT STILL ALARMED. AS A RESULT, THE PUMP WAS SWITCHED OUT SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THEY STATED NO DELAY OR INTERRUPTION IN INTRA-AORTIC BALLOON PUMP (IABP) THERAPY; HOWEVER, THEY DID HAVE TO SWITCH OUT THE PUMP. THE PATIENT OUTCOME IS WELL. AFTER THE ENGINEER REPLACED THE DRAIN VALVE, THE PUMP WORKED NORMALLY. IT WAS CONFIRMED THAT THE DRAIN VALVE MALFUNCTIONED. THERE ARE NO STRIPS AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 INTRA-AORTIC BALLOON PUP PRODUCTS DSP ARROW INTL., INC. KC0098082

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR INTRA-AORTIC BALLOON