BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8FR-30 CC FOS

    MDR report key: 1031466 · Received April 18, 2008

    Report

    Report Number
    1219856-2008-00200
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    INFO RECEIVED BY CALL REPORT 2008. IT WAS REPORTED BY THE CLINICIAN THAT THE PT HAD A FIBER OPTIX SENSOR (FOS) INTRA-AORTIC BALLOON (IAB) INSERTED THAT MORNING. EVER SINCE PT WAS RECEIVED IN THE INTENSIVE CARE UNIT, THEY HAVE BEEN EXPERIENCING HIGH PRESSURE, KINKED CATHETER ALARMS. PT IS "SHORT AND HEAVY" WITH A 30CC IAB IN PLACE. REGISTERED NURSE (RN) IS UNABLE TO SEE THE INSERTION SIGHT TO SEE ANGLE OF INSERTION. ALSO STATED PT COULDN'T LAY FLAT & HEAD OF BED (HOB) IS ELEVATED. CLINICAL ON CALL EXPLAINED THAT ANGLE OF INSERTION AND HOB ELEVATED IS PROBABLY A KINKING CATHETER. INSTRUCTED HIM TO TRY TO LOWER HOB TO 30 DEGREES, PLACE BLANKET UNDER HIPS TO HYPEREXTEND AND IF NO CHANGE, ATTEMPT TO DECREASE VOLUME OF BALLOON IN SMALL INCREMENTS. RN HAD CLINICAL ON CALL HOLD ON THE LINE WHILE HE ATTEMPTED THE ABOVE. HE RETURNED TO THE PHONE SEVERAL MINUTES LATER AND DESPITE HIS EXPLANATION TO THE PHYSICIAN AS TO POSSIBLE KINKING CAUSES, PHYSICIAN DECIDED TO REMOVE THE IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8FR-30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK