BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19278163 · Received May 9, 2024

    Report

    Report Number
    9617594-2024-00568
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 22, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619068615
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER PHONE IS (B)(6). THE DEVICE IS AVAILABLE FOR EVALUATION- IT HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG: 5/15/2024. THE REPORTED COMPLAINT OF A LEAK WAS CONFIRMED ON THE RETURNED SET. AN IMAGE WAS PROVIDED BY THE CUSTOMER INDICATING THE AREA OF THE LEAK. NO VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED SET. THE TRANSDUCER WAS ELECTRICALLY TESTED, AND THE TRANSDUCER WAS NOT ABLE TO BE ZEROED. THE SET WAS PRIMED, AND PRESSURE LEAK TESTED, AND A LEAK WAS OBSERVED FROM THE WALLS OF THE BLUE HOUSING. THERE WOULD BE A LEAK FROM THE WALLS OF THE BLUE HOUSING ONLY IF THERE IS A LEAK INSIDE THE BLUE HOUSING. WHEN THE TRANSPAC WAS CUT OPEN, CORROSION WAS OBSERVED INSIDE THE BLUE HOUSING. THE MICROCHIP WAS LOOSE, AND A PART OF THE GEL CUP GOT INSIDE THE BLUE HOUSING. THIS COULD LEAD THE TRANSDUCER TO STOP MONITORING. THE PROBABLE CAUSE OF THE GEL CUP WHICH GOT INSIDE THE MICROCHIP HAD OCCURRED DUE TO OVER PRESSURIZING OF THE SET DURING USE. THE PROBABLE CAUSE OF THE CORROSION HAD OCCURRED DUE TO FLUID INGRESS INSIDE THE BLUE HOUSING DURING USE. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE, MACRODRIP WHERE THE CUSTOMER REPORTED A LEAKAGE DURING INFUSION. THE SET WAS REPLACED, AND THERAPY RESUMED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383848 TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE, TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13705810 00840619068615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown