BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC

    MDR report key: 9944395 · Received April 9, 2020

    Report

    Report Number
    9617594-2020-00110
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    November 18, 2019
    Report Date
    December 18, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619033804
    PMA / PMN Number
    K061573
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED LIST# 425850405, MONITORING KIT WAS RECEIVED FOR EVALUATION. THE REPORTED COMPLAINT OF "PRESSURE TUBING CONNECTION WAS LEAKING" WAS CONFIRMED. NO VISUAL ANOMALIES WERE OBSERVED. WHEN PRIMED AND PRESSURE LEAK TESTED, A CHANNEL LEAK WAS OBSERVED FROM THE PRESSURE TUBING AND THE MALE LUER. A PULL TEST WAS CONDUCTED BETWEEN THE BONDS THROUGH WHICH A CHANNEL LEAK WAS OBSERVED. THE TUBING PULLED OFF FROM THE LUER AT 13.3 LBS WHICH IS ABOVE THE SPECIFICATION LIMITS OF 6 LBS. WHEN THE BOND SURFACE OF THE PRESSURE TUBING WAS EXAMINED, INSUFFICIENT SOLVENT WAS OBSERVED ON ONE SIDE OF THE PRESSURE TUBING THROUGH WHICH A CHANNEL LEAK WAS OBSERVED. THE PROBABLE CAUSE OF THE CHANNEL LEAK BETWEEN THE PRESSURE TUBING AND THE MALE LUER HAD OCCURRED DUE TO INSUFFICIENT SOLVENT APPLIED DURING ASSEMBLY PROCESS. A DEVICE HISTORY REVIEW (DHR) FOR LOT# 3981038 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN THE OPERATING ROOM AND INVOLVED A TRANSPAC IV MONITORING KIT, 84¿ DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP THAT DURING PRIMING, THE PRESSURE TUBING CONNECTION RIGHT AFTER THE FLUSH DEVICE WAS LEAKING. THE DEVICE WAS REPLACED. THERE WERE NO OBVIOUS DEFECTS NOTED ON THE TUBING AND THERE WAS NO MATING DEVICE ATTACHED ON THE TUBING. THERE WAS NO SERIOUS INJURY, DEATH OR POTENTIAL FOR DEATH OR SERIOUS INJURY, THE PRODUCT WAS NOT USED ON A PATIENT AT THE TIME OF THE INCIDENT AND THERE WAS NO DELAY CRITICAL THERAPY WHEN THE PROBLEM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408331 TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3981038 00840619033804

    Patients

    Seq Age Sex Outcome Treatment
    1