BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1230382 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00512
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 7, 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
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE IAB WAS CONNECTED TO THE PUMP. HOWEVER, THE PUMP (IAP-0500J) DID NOT "READ THE FIBEROPTIX SENSOR (FOS)." NEVERTHELESS, THE MD INSERTED THE SHEATH VIA THE RIGHT FEMORAL ARTERY. THE MD USED THE TRANSDUCER RATHER THAN THE FOS TO MONITOR THE PT. THE PUMP ALARMED "BLOOD IN GAS DRIVELINE TUBING" 15 MINUTES AFTER THE IAB THERAPY BEGAN. BLOOD WAS DETECTED IN THE HELIUM TUBING. THE MD REMOVED THE IAB AND REPLACED IT WITH ANOTHER IAB. THERE WERE NO REPORTED PT COMPLICATIONS.

    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. MF8029257

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK AUTOCAT2 WAVE BALLOON PUMP