BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2922173 · Received January 16, 2013

    Report

    Report Number
    1219856-2013-00011
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE CATH LAB SHORTLY AFTER INSERTION. RELEVANT MEDICAL HISTORY/DIAGNOSIS/MEDICATIONS/INDICATION FOR USE: EMERGENT INSERTION. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH THE SHEATH VIA FEMORAL ARTERY WITH NO ISSUES. THE IAB WAS RECOGNIZED AND ZEROED CORRECTLY, BUT DURING THE CASE THE FIBEROPTIX SENSOR (FOS) ARTERIAL PRESSURE (AP) WAVEFORM WAS INTERMITTENT UNLESS THEY JUGGLED THE CONNECTION. THERE WAS AN FOS ERROR ALARM CODE RECEIVED AND THE STAFF DID NOT REMEMBER WHAT IT SAID. AT ONE POINT THE STAFF SWITCHED THE PUMP OUT, BUT THIS DID NOT RESOLVE THE ISSUE SINCE THEY CONTINUED TO LOSE THE FOS AP WAVEFORM. AS A RESULT, THEY SELECTED THE TRANSDUCER AND CONTINUED THERAPY IN MANUAL MODE. THERE WAS NO REPORT OF PATIENT DEATH COMPLICATIONS OR INJURY. NO MEDICAL SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A DELAY OR INTERRUPTION IN THERAPY ONLY WHEN THEY LOST SIGNAL AND WHEN THEY HAD TO SWITCH OUT THE PUMP ((B)(4)). THE PATIENT OUTCOME WAS OKAY. THERE WERE NO STRIPS OR X-RAYS PERFORMED. PER THE SALES REPRESENTATIVE, THE M.D. STATED HIS DISAPPOINTMENT THAT THERE WAS NO USE OF THE FOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23782 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF2104425

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP