BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR

    MDR report key: 9281460 · Received November 5, 2019

    Report

    Report Number
    9617594-2019-00380
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    September 11, 2019
    Report Date
    September 18, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619035730
    PMA / PMN Number
    K052828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODRIP THAT HAD A WHITE WIRE BROKEN. THE EVENT OCCURRED DURING PRIMING OF HEPARIN SALINE USING A PHILIPS MONITOR FOR BLOOD PRESSURE MONITORING. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT, AND NO DELAY IN CRITICAL THERAPY. TESTING AND INVESTIGATION WAS UNABLE TO CONFIRM THE COMPLAINT; HOWEVER, THERE WAS A SEPARATION OF THE 48¿ ARTERIAL PRESSURE TUBING BETWEEN THE MALE AND FEMALE LUER. THE END OF THE TUBING HAD THE PRESENCE OF UV ADHESIVE, BUT IT HAD A TACKY FEELING. THE PROBABLE CAUSE OF THE TUBING SEPARATION WAS THE UV ADHESIVE NOT BEING FULLY CURED AT THE BOND BETWEEN THE ARTERIAL TUBING AND FEMALE LUER. THIS DEFECT WAS DUE TO A MANUAL MANUFACTURING PROCESS ERROR IN ENSENADA. A DEVICE HISTORY REVIEW FOR LOT# 4071800 AND RELEVANT COMMODITIES WERE REVIEWED AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077417 TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4071800 00840619035730

    Patients

    Seq Age Sex Outcome Treatment
    1