BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 782430 · Received December 27, 2004

    Report

    Report Number
    8030665-2004-00094
    Event Type
    Malfunction
    Date Received
    December 27, 2004
    Date of Event
    October 29, 2004
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: NO INDICATION OF THE REPORTED DEFECT FOUND DURING A REVIEW OF THE DEVICE HISTORY RECORD. LOT MET ALL RELEASE CRITERIA. SAMPLE ANALYSIS REPORT: DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE A, PARTIAL KINK WAS FOUND ON THE ARTERIAL LINE JUST BELOW THE ADAPTER CONNECTOR ON THE MAIN LINE. RESULTS: THE KINK COULD BE CAUSED DUE TO AN INCORRECT COILING OF THE ARTERIAL LINE. CORRECTIVE ACTION: THE COILING FIXTURE WAS MODIFIED AND NEW MODULE #5770 WAS CREATED TO IMPROVE THE COILING TECHNIQUE ON THE CODE 03-2722-3 AND WAS IMPLEMENTED ON SEPTEMBER 30, 2004. THE FIRST LOT # WAS 4LR910 AND FOR THE SERIES 03-2742-9, THIS WAS IMPLEMENTED ON OCTOBER 31,2004. THE FIRST LOT # WAS 4NR948. WE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT PRIOR TO USE, A KINK WAS NOTED IN THE ARTERIAL LINE JUST BELOW THE BLOOD PUMP SEGMENT.THE SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET BLOODLINE FJK REYNOSA MANUFACTURING NA 4JR255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA