BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1203414 · Received October 17, 2008

    Report

    Report Number
    1219856-2008-00480
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REGISTERED NURSE (RN) VIA THE HOTLINE THAT "THEY WERE HAVING HELIUM LOSS ALARMS ON THE PUMP". THE PATIENT'S HEART RATE WAS 60-80. THE RN THEN EXPLAINED TO THE CLINICAL SUPPORT SPECIALIST (CSS) EVERYTHING HE DID TO TROUBLESHOOT THE ALARM. THE RN STATED THAT "THERE WAS NO BLOOD, THEY CHANGED OUT THE DEVICE LINE TUBING, THERE WAS NO KINK, AND NO ECTOPY WITH NO IMPROVEMENT". PRIOR TO CALLING THE HOTLINE, THE PATIENT WAS TAKEN BACK TO THE CATH LAB AND ANOTHER INTRA-AORTIC BALLOON (IAB) WAS INSERTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. IN 2008, THE RN SENT A PRODUCT COMPLAINT REPORT STATING THE EVENT INVOLVED A MALE PATIENT. THE IAB WAS INSERTED THROUGH A SHEATH INTO THE FEMORAL ARTERY. THE PATIENT IS IN STABLE CONDITION AND IS NOW IN THE INTENSIVE CARE UNIT DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF8082395

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR INTRA-AORTIC BALLOON PUMP (BRAND UNK)