BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84

    MDR report key: 18024004 · Received October 27, 2023

    Report

    Report Number
    9617594-2023-00891
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    May 31, 2023
    Report Date
    July 31, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** INCORRECT PRIMARY DI NUMBER PROVIDED IN THE INITIAL MDR. CORRECTION IN D4 - PRIMARY UDI NUMBER.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED. LIST #011-46110-29, TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84" RED STRIPE ARTERIAL PRESSURE TUBING AND 2 NEEDLELESS VALVES; LOT #6032802. THE REPORTED COMPLAINT OF BACK FLOW WAS CONFIRMED BASED ON THE RECEIVED DEVICE. DURING VISUAL INSPECTION, BLOOD WAS OBSERVED ALL THE WAY TILL THE DRIP CHAMBER ON THE RETURNED SET. A CRACK WAS ALSO OBSERVED ON THE FEMALE LUER OF THE SQUEEZE FLUSH DEVICE. NO CRAZING WAS OBSERVED NEAR THE CRACK. AFTER DECONTAMINATION, WHEN THE RETURNED SET WAS PRIMED AND PRESSURE LEAK TESTED, A LEAK WAS OBSERVED FROM THE CRACK ON THE SQUEEZE FLUSH DEVICE. WHEN THE SAFESET RESERVOIR WAS FLUSHED, THE FLUID HAD PASSED THE LINE IN THE INTENDED DIRECTION. NO BACK FLOW WAS OBSERVED. THE PROBABLE CAUSE OF THE CRACK ON THE SQUEEZE FLUSH DEVICE IS UNKNOWN. THE PROBABLE CAUSE OF THE BLOOD BACKFLOW ON THE SET COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. THE DEVICE HISTORY REPORT (DHR) FOR LOT 6032802 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84" RED STRIPE ARTERIAL PRESSURE TUBING AND 2 NEEDLELESS VALVES. THE CUSTOMER REPORTED A MALFUNCTION WHERE THE INCIDENT WAS OBSERVED DURING PATIENT USE. THE RINSING SYRINGE FROM ONE LINE, PLACED IN SERIES, INJECTED TOWARDS THE PRESSURE BAG AND NOT TOWARDS THE ARTERIAL CATHETER (THE STOPCOCK WAS PLACED CORRECTLY). THE STATUS OF THE PRODUCT AT THE TIME OF EVENT IS DURING INJECTION. THERE WAS A DELAY IN THERAPY FOR ABOUT 20 MIN (TWO CIRCUITS TO RE-PRIME AND REINSTALL). THE DRUG INFUSED WAS ISOTONIC SOLUTION FOR ARTERIAL CATHETER. THE PATIENT¿S CONDITION WAS CATEGORIZED AS UNMODIFIED. THERE WAS MEDICAL INTERVENTION REQUIRED AND IT WAS THE REMOVAL AND REFITTING OF THE DEVICE UNDER STRICT ASEPTIC CONDITIONS TWICE. THE DEVICE WAS REPLACED, AND THERAPY COMPLETED. NO PHYSICAL DEFECTS NOTED BEFORE USE. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENTS/HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207559 TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84 TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6032802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARTERIAL CATHETER, MFR UNK| ISOTONIC SOLUTION, MFR UNK