BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2

    MDR report key: 3185040 · Received June 18, 2013

    Report

    Report Number
    1219856-2013-00148
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 25, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    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 CARDIAC CARE UNIT DURING USE. THE DOCTOR INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH VIA LEFT FEMORAL ARTERY WITH NO ISSUES. APPROXIMATELY 10 HOURS LATER THE INTRA-AORTIC BALLOON PUMP (IABP), S/N (B)(4), ALARMED EVERY 3 MINUTES DURING USE. THE ALARM SHOWED POSSIBLE HELIUM LEAK. AS A RESULT, THE PUMP WAS SWITCHED OUT SUCCESSFULLY. THE DOCTOR STATED THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY. THE PATIENT OUTCOME IS THE PATIENT IS STILL UNDER TREATMENT. THE ENGINEER CHECKED AND CONFIRMED DRAIN VALVE MALFUNCTION. THE WARRANTY HAS EXPIRED SO THE HOSPITAL BOUGHT A NEW ONE (96-3006-001W, SN: (B)(4)). AFTER THE PUMP WORKED FOR A MONTH AND A HALF, IT TURNED TO BE THE SAME PROBLEM. THERE WERE TWO PUMPS IN THIS HOSPITAL SO THE DOCTOR REPLACED WITH A GOOD ONE AFTER ONE PUMP WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277440 AUTOCAT 2 INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR INTRA-AORTIC BALLOON