BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 789317 · Received December 17, 2004

    Report

    Report Number
    8030665-2004-00089
    Event Type
    Malfunction
    Date Received
    December 17, 2004
    Date of Event
    November 22, 2004
    Report Date
    December 16, 2004
    Manufacturer
    REYNOSA MFG
    Product Code
    FJK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW AND EXTRUSION INSPECTION RECORD: NO INDICATION OF THE REPORTED DEFECT FOUND DURING A REVIEW OF THE DEVICE HISTORY RECORD. LOT MET ALL RELEASE CRITERIA. SAMPLE ANALYSIS REPORT: DURING 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 A WRONG COILING OF THE ARTERIAL LINE. CORRECTIVE ACTION: THE COILING FIXTURE WAS MODIFIED AND NEW MODULE WAS CREATED TO IMPROVE THE COILING TECHNIQUE ON THE CODE 03-2722-3 AND WAS IMPLEMENTED IN 2004 AND FOR SERIES 03-2742-9 THIS WAS IMPLEMENTED THE FOLLOWING MONTH. FIRST LOT 4NR948. WE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT PRIOR TO USAGE, A KINK WAS NOTED AT THE END OF THE BLOOD PUMP SEGMENT OF THE ARTERIAL LINE. THE DEVICE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET BLOODLINE FJK REYNOSA MFG NA 4KR076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA