BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, SAFESET¿ RESERVOIR AND 2 NEEDL

    MDR report key: 16792338 · Received April 21, 2023

    Report

    Report Number
    9617594-2023-00149
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    January 12, 2023
    Report Date
    February 3, 2023
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - LOT # POSSIBLE LOTS WITH D4 - EXPIRATION DATE AND H4 - DEVICE MFG DATE: 6031961 (EXP DATE OF 08/01/2025 AND MFG DATE OF 09/01/2022). 11957767 (EXP DATE OF 11/01/2025 AND MFG DATE OF 11/01/2022). RECEIVED ONE USED. LIST #011-46108-05, TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, SAFESET¿ RESERVOIR AND 2 NEEDLELESS VALVES; LOT #UNKNOWN. THE REPORTED COMPLAINT OF TUBING SEPARATION WAS CONFIRMED ON THE RETURNED SET. DURING VISUAL INSPECTION, THE 61.5" PRESSURE TUBING WAS FOUND SEPARATED FROM THE RED MALE LUER. THE PRESSURE TUBING WAS FOUND TACKY AT THE BOND SITE. THE SEPARATION OF THE BOND WAS DUE TO THE PRESSURE TUBING BEING TACKY. THE PROBABLE CAUSE OF THE PRESSURE TUBING BEING TACKY IS DUE TO THE UV ADHESIVE ON THE TUBING NOT BEING FULLY CURED DURING ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, SAFESET¿ RESERVOIR AND 2 NEEDLELESS VALVES. THE CUSTOMER REPORTED THAT AT AROUND 10:00 P.M., AN ARTERIAL PRESSURE SENSOR IS PLACED WITH A BLOOD SAVER BEFORE GOING TO THE OPERATING ROOM TO CARRY OUT AN EXTERNAL VENTRICULAR DERIVATION IN THE FACE OF INTRACRANIAL HYPERTENSION AND INSTALLATION OF AN INTRACRANIAL PRESSURE SENSOR AT THE SAME TIME. SOMETIME AFTER THE PROCEDURE, A NURSE NOTICES BLOOD IN THE PATIENT'S BED (BLOOD LOSS BUT NO CLINICAL CONSEQUENCES) AND NOTICES THAT THE TUBING THAT CONNECTS THE ARTERIAL CATHETER WITH THE BLOOD SAVER IS UNBLOCKED AT THE LEVEL OF THE LUER LOCK HUB ITSELF CONNECTED TO THE DISTAL 3-WAY STOPCOCK (DISTAL TO THE BLOOD PRESSURE SENSOR). THE CUSTOMER REPLACED THE SENSOR OF ARTERIAL PRESSURE BY AN EDWARDS SENSOR REFERENCE PX272 WITHOUT BLOOD SAVER. THE CUSTOMER ALSO REPORTED A MISUSE IN THE SERVICE DURING THE REALIZATION OF INFUSION¿S SET-UP. THE MEDICAL TEAM TOOK CARE OF THE PATIENT BY FOLLOWING THE RULES ASSOCIATED WITH THE RISKS AFFECTING A CATHETER, NAMELY THE TRENDELENBURG POSITION AND THE CLAMP OF THE CATHETER. THE INCIDENT WAS OBSERVED AFTER THE INSTALLATION BY A NURSE WHO CAME TO SEE THE PATIENT'S CONDITION. ANOTHER BLOOD PRESSURE SENSOR WAS NEEDED. THERE WERE NO EXPOSURE ACCIDENTS, HEMOVIGILANCE HAVING RULED THAT THEY ARE NOT CONCERNED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446662 TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, SAFESET¿ RESERVOIR AND 2 NEEDL TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Male PX272-ARTERIAL PRESSURE, EDWARDS LIFESCI MFR