BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB:7.5 FR - 30 CC

    MDR report key: 1881862 · Received October 8, 2010

    Report

    Report Number
    1219856-2010-00706
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT IN THE CARDIAC CARE UNIT WAS ON THE INTRA-AORTIC BALLOON PUMP (IABP). THE PT HAD CALCIFIED/ARTIFICIAL VESSELS AND THE BALLOON WAS INSERTED WITHOUT A SHEATH. AFTER ABOUT 56 HOURS, THE PUMP GAVE AN ALARM. THE BALLOON WAS RUPTURED AND BLOOD MADE ITS WAY BACK TO THE PUMP. THE PUMP STOPPED WORKING. THE BALLOON WAS REMOVED AND NO NEW IAB WAS INSERTED. THERE WAS NO PT DEATH, COMPLICATION OR INJURIES REPORTED. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE OUTCOME OF THE PT IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB:7.5 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF9067248

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR