BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC TRIFURCATED MONITORING KIT, 60" TUBING, 3 3 ML FLUSH DEVICE, MICRODRIP

    MDR report key: 10534624 · Received September 15, 2020

    Report

    Report Number
    9617594-2020-00394
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 17, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619030032
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D10: DATE RETURNED TO MANUFACTURER IS 9/16/2020. H10: ONE (1) USED PARTIAL LIST # 011-0J988-01, TRANSPAC¿ TRIFURCATED MONITORING KIT, 60" TUBING, 3 3 ML FLUSH DEVICE, MICRODRIP; LOT # 3964739 WAS RECEIVED FOR EVALUATION. THE REPORTED COMPLAINT OF DISCONNECTION WAS CONFIRMED ON THE RETURNED SET. DURING VISUAL INSPECTION, THE 60" PRESSURE TUBING WAS RECEIVED BROKEN FROM THE WINGED MALE LUER. THE WINGED MALE LUER WAS NOT RECEIVED FOR EVALUATION. IT IS UNKNOWN HOW AND WHEN THE TUBING BREAKAGE HAD OCCURRED. THE PACKAGING WAS OBSERVED AND NO INDENTATION WAS OBSERVED WHICH COULD LEAD TO THE TO THE REPORTED COMPLAINT. THE RETURNED TRIFURCATED MONITORING SET WAS PRIMED AND PRESSURE LEAK TESTED AND NO LEAKS WERE OBSERVED. THE PROBABLE CAUSE FOR THE BROKEN PRESSURE TUBING IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED. THE DEVICE IS NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO TRANSPAC TRIFURCATED MONITORING KITS THAT DURING PRIMING, PART OF THE PRESSURE LINE DISCONNECTED WHERE IT SHOULD HAVE BEEN BONDED TO. THERE WERE NO ADDITIONAL INFORMATION PROVIDED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE FIRST OF TWO EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997938 TRANSPAC TRIFURCATED MONITORING KIT, 60" TUBING, 3 3 ML FLUSH DEVICE, MICRODRIP TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3964739 00840619030032

    Patients

    Seq Age Sex Outcome Treatment
    1 IV FLUIDS, BAXTER| IV FLUIDS, BAXTER