BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7 FR -30 CC

    MDR report key: 1963642 · Received December 21, 2010

    Report

    Report Number
    1219856-2010-00916
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE HEMODYNAMIC DEPARTMENT THE PHYSICIAN INSERTED THE INTRA-AORTIC BALLOON (IAB). THE PUMP SHOWED AN ALARM MESSAGE OF HELIUM LEAKAGE WHEN THE DRIVELINE AND CATHETER WERE CONNECTED TO THE DATASCOPE INTRA-AORTIC BALLOON PUMP. THE LEAKAGE EMERGED AT THE CONNECTION OF THE DRIVELINE AND THE HELIUM OUTLET. THE PHYSICIAN FOUND THE PROBLEM AND REPLACED THE CATHETER SUCCESSFULLY. THERE WAS A DELAY OF 4 HOURS NOTED WITH NO PATIENT DEATH, INJURIES, OR COMPLICATIONS. ADD'L INFO RECEIVED FROM THE DISTRIBUTION MGR ON (B)(4) 2010 STATED "THE CATHETER WAS REPLACED BY A DATASCOPE CATHETER THAT WORKED PROPERLY. THE PT WAS IN BAD CONDITION AND UNSTABLE, IT TOOK 4 HOURS FOR THE PHYSICIAN TO STABILIZE THE PT. THE FIRST CATHETER WAS NOT REMOVED DURING THIS TIME FRAME, THE PUMP CONSTANTLY COMMUNICATED THE ALARM MESSAGE. THE PT SURVIVED AND SHE IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7 FR -30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF0032268

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DATASCOPE INTRA-AORTIC BALLOON PUMP