BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED ST

    MDR report key: 9371999 · Received November 25, 2019

    Report

    Report Number
    9617594-2019-00407
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 9, 2019
    Report Date
    November 11, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    PMA / PMN Number
    K052828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) USED LIST # 011-46106-23, TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED STRIPE PRESSURE TUBING, AND 2 NEEDLELESS VALVES WAS RECEIVED ON DECEMBER 12, 2019 FOR EVALUATION. THE REPORTED COMPLAINT OF PLUNGER DETACHED FROM PLUNGER TIP WAS CONFIRMED ON THE RETURNED KIT. THE PLUNGER TIP OF THE SAFESET RESERVOIR WAS SEPARATED AND UNABLE TO BE PULLED BACK. THE PROBABLE CAUSE WAS DUE TO THE CLIPS NOT BEING FULLY INSERTED (ENGAGED) INTO THE MATING COMPONENT DURING THE MANUFACTURING PROCESS IN ENSENADA. THE DEVICE HISTORY REVIEW FOR LOT NUMBERS 4140117, 4176540, 4156588, AND 4176540 WERE REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. IT IS YET TO BE RECEIVED. POSSIBLE LOTS: 4140117, MFR DATE 2019-07-01, EXP DATE 2022-07-01; 4176540, MFR DATE 2019-07-01, EXP DATE 2022-07-01; 4156588, MFR DATE 2019-07-01, EXP DATE 2022-07-01.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE EVENT OCCURRED SEVERAL MINUTES AFTER THE CATHETER WAS INSTALLED AND DURING THE FIRST USE OF THE TUBING WITH BLOOD COLLECTION. THE NURSE WAS ATTEMPTING TO COLLECT BLOOD FROM A TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED STRIPE PRESSURE TUBING AND 2 NEEDLELESS VALVES WHEN THE PISTON PIN BROKE ON THE BLACK PLASTIC AND BLOOD CAME BACK AND FLOODED THE BED. THE TUBING WAS REPLACED, AND THERAPY WAS RESUMED. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT NOR HUMAN HARM AND NO DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165041 TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED ST TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 500ML NACL, UNK MFR