BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2922150 · Received January 16, 2013

    Report

    Report Number
    1219856-2013-00010
    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 DID NOT ZERO CORRECTLY. THERE WAS AN FIBEROPTIX SENSOR (FOS) ERROR ALARM CODE RECEIVED AND THE STAFF DID NOT REMEMBER WHAT IT SAID. THE DIFFERENCE IN PRESSURE OF MEAN ARTERIAL PRESSURE (MAP) ON THE INTRA-AORTIC BALLOON PUMP (IABP) WAS IN THE 80'S AND THE OTHER ARTERIAL PRESSURE (AP) SOURCES WERE IN THE 170'S. THE ATTEMPT TO CALIBRATE DID NOT WORK ACCORDING TO THE STAFF BECAUSE THE WAVEFORM FROM THE FOS WAS INTERMITTENT. THE AP SELECT WAS SET TO TRANSDUCER, THE TRANSDUCER WAS ZEROED PROPERLY AND THE THERAPY CONTINUED WITH TRANSDUCED AP WAVEFORM. AS A RESULT, THEY 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 FOR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24568 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF2114565

    Patients

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