BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESET 84" ARTERIAL PRESSURE TUBING, RESERVOIR, AND 2 NEEDLELESS VALVES

    MDR report key: 12244997 · Received July 29, 2021

    Report

    Report Number
    9617594-2021-00211
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 7, 2021
    Report Date
    July 2, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    KRA
    PMA / PMN Number
    K932188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED LIST #42322-66, SAFESET¿ 84" ARTERIAL PRESSURE TUBING, RESERVOIR, AND 2 NEEDLELESS VALVES; LOT #UNKNOWN. THE REPORTED COMPLAINT OF LEAKAGE WAS CONFIRMED. DURING VISUAL INSPECTION, AN INSERTION DEPTH WAS OBSERVED BETWEEN THE FEMALE LUER OF THE 12" PRESSURE TUBING AND THE MALE LUER OF THE 3 WAY STOPCOCK. THIS CONNECTION IS BONDED. WHEN THE SET WAS PRIMED AND PRESSURE LEAK TESTED, A LEAK WAS OBSERVED FROM THE BOND SITE BETWEEN THE FEMALE LUER OF THE 12" PRESSURE TUBING AND THE MALE LUER OF THE 3- WAY STOPCOCK. THE LEAK HAD OCCURRED DUE TO THE FEMALE LUER NOT BEING FULLY INSERTED INTO THE MALE LUER OF THE STOPCOCK. THE PROBABLE CAUSE OF THE LEAKAGE HAD OCCURRED DUE TO THE FEMALE LUER OF THE 12" PRESSURE TUBING NOT BEING FULLY INSERTED INTO THE MALE LUER OF THE STOPCOCK DURING MANUAL ASSEMBLY. THE LOT REVIEW COULD NOT BE CONDUCTED BECAUSE THERE IS NO LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SAFESET 84" ARTERIAL PRESSURE TUBING, RESERVOIR AND 2 NEEDLELESS VALVES WHERE IT WAS REPORTED AN EXCESSIVE BLOOD LEAK AT BLOOD DRAW PORT, THE MOST DISTAL FROM SAFESET SYRINGE. IT WAS MENTIONED THAT THE STAFF STATED, A CENTRAL LINE WAS CONNECTED WITH AN ICU MEDICAL SAFESET PER PROTOCOL. THE CENTRAL LINE BACKED UP WITH BLOOD AFTER THE SYSTEM FLUSHED. THE CONNECTOR FROM STERILE FIELD TO SAFESET WAS CHECKED FOR TIGHTNESS. THE LINE RE-FLUSHED AND BLOOD BACKED UP AGAIN. AN EXCESSIVE LEAKING WAS NOTED AT THE SYSTEM BLOOD DRAW PORT, THE MOST DISTAL FROM SAFESET SYRINGE. THE SYSTEM WAS RE-FLUSHED AND BLOOD BACKED UP AGAIN AND WAS NOTED WITH EXCESSIVE LEAKING OF BLOOD AT THE SAME SITE. THE LINE FROM PATIENT WAS CLAMPED, THE PHYSICIAN WAS NOTIFIED, AND THE DEFECTIVE SAFESET WAS DISCONNECTED AND REMOVED. THE NEW CENTRAL LINE WITH NEW SAFESET WAS SET UP AND RE-CONNECTED TO PATIENT LINE PER PROTOCOL WITHOUT INCIDENT. THE LEAKING NO LONGER OCCURRED. THERE WAS A PATIENT INVOLVEMENT AND A DELAY IN THERAPY BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140978 SAFESET 84" ARTERIAL PRESSURE TUBING, RESERVOIR, AND 2 NEEDLELESS VALVES CATHETER, CONTINUOUS FLUSH KRA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 42322-66 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1