BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 2540863 · Received April 16, 2012

    Report

    Report Number
    1219856-2012-00138
    Event Type
    Malfunction
    Date Received
    April 16, 2012
    Date of Event
    March 23, 2012
    Report Date
    April 12, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER THE INSTRUCTIONS FOR USE AND INSERTED VIA THE PT'S FEMORAL ARTERY USING A SHEATH. THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY BEGAN WITHOUT ISSUE HOWEVER, 45 MINUTES INTO THE IABP THERAPY THE PUMP ALARMED WITH A "HELIUM LOSS ERROR." ACCORDING TO THE RISK MANAGER, "IT WAS IAB KINKED, OR THE IAB HAD A LEAK, OR THE HELIUM TANK DID NOT HAVE ENOUGH HELIUM. THE EXACT ERROR WAS NOT JOTTED DOWN ON PAPER BECAUSE OF THE MEDICAL CARE THIS PT WAS RECEIVING BY THE CATH LAB STAFF AT THE TIME OF THE ALARM. THE STAFF DID TROUBLE SHOOT THE ALARM AND FOUND THAT THE IAB WAS NOT KINKED AND THE HELIUM TANK WAS FULL. THERE WAS NO MOTION AROUND THE INSERTION SITE OF THIS IAB NOR WAS THE PT MOVED." THE IAB WAS REMOVED AND THE PT RECEIVED AN ALREADY PLANNED "IMPELLA" DEVICE. THERE WAS NO REPORTED PT DEATH OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE IABP THERAPY WAS INTERRUPTED/DELAYED HOWEVER THERE WAS NO PT HARM. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT OUTCOME IS STABLE.

    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. KR1111932

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON