BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACAT 1 IAM PUMP ASSEMBLY

    MDR report key: 1172865 · Received September 19, 2008

    Report

    Report Number
    1219856-2008-00441
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K965209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, THE SYSTEM ERROR 7 ALARM RANG WHEN THE POWER SUPPLY WAS TURNED ON. THE PUMP WAS REBOOTED, BUT THE SAME ISSUE OCCURRED AGAIN. A THIRD REBOOT WAS TRIED AND THAT TIME THERE WAS NO ALARM. ASSUMING THE PUMP WAS NOT THE ISSUE, THE PUMP WAS USED ON THE PATIENT. AT ABOUT THREE DAYS LATER, THE SYSTEM ERROR 7 ALARM SOUNDED AGAIN, BUT THE CLINICIAN MANAGED TO RESOLVE THE PROBLEM AND CONTINUED TO USE IT ON THE PATIENT. EVENTUALLY, FOR FEAR OF THE SAME ISSUE CONTINUING, THE PUMP WAS EXCHANGED WITH ANOTHER PUMP. THE FIRST PUMP WAS MOVED TO THE ME ROOM WHERE IT WAS CHECKED BY STAFF, WHO CONFIRMED THE ISSUE AS THE ALARM SOUNDED AGAIN. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACAT 1 IAM PUMP ASSEMBLY INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN