BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF

    MDR report key: 14713749 · Received June 16, 2022

    Report

    Report Number
    9617594-2022-00176
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 19, 2022
    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
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. THE CUSTOMER IDENTIFIED 3 POSSIBLE LOT NUMBERS: (PLOTS): 5201049 (EXPIRY DATE 02/01/2024, MFR DATE: 03/01/2021), 5254594 (EXPIRY DATE: 04/01/2024, MFR DATE: 05/01/2021), 5487785 (EXPIRY DATE: 07/01/2024, MFR DATE: 12/01/2020).

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT. IT WAS REPORTED THAT PRIOR TO CONNECTION TO THE PATIENT AND AFTER THE LINE WAS PRIMED, THE SAFESET BECAME LOOSE AND DISCONNECTED BETWEEN THE RESERVOIR AND THE LINE. THE DILUENT SET WAS DISCONNECTED FROM THE TWO WAY VALVE AND IT APPEARED THAT THE ADHESIVE HASN¿T STUCK. ADHESIVE WAS OBSERVED AT THE POINT OF DISCONNECTION. THE SAFESET WAS REPLACED WITH A NEW ONE THAT WAS NOT LOOSE AND DID NOT APPEAR THAT IT WOULD COME APART IN THE SAME AREA. THE NUMBER OF HOURS THE DEVICE WAS USED WAS 0.1. SOMEONE BECOME AWARE OF THE ISSUE WHEN THE DEVICE CAME APART AS THE NURSE WAS PRIMING. NO MEDICATION WAS BEING USED WITH THE PRODUCT. THERE WAS NO LEAKAGE. ALTHOUGH THERE WAS A DELAY IN THERAPY, THERE WAS NO HUMAN HARM. THIS CAPTURES THE SECOND OF TWO EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312914 TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HEPARIN SODIUM 0.45% SODIUM CHLORIDE, MFR UNK.