BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS,

    MDR report key: 9439981 · Received December 9, 2019

    Report

    Report Number
    9617594-2019-00417
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 13, 2019
    Report Date
    November 20, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619041199
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION D10: THE DEVICE WAS RETURNED FOR INVESTIGATION ON (B)(6)2019 FOR INVESTIGATION. H10: RECEIVED ONE UNUSED LIST# 011-46103-87, TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84" TUBING, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT). THE REPORTED COMPLAINT OF "DISCONNECTED LINE" WAS CONFIRMED. DURING VISUAL INSPECTION, THE TUBING BREAKAGE WAS OBSERVED AT THE SAFESET POCKET. A PULL TEST WAS CONDUCTED AT A REPRESENTATIVE BOND AND DID NOT FIND ANYTHING UNUSUAL. THE PROBABLE CAUSE FOR THE DISCONNECTED LINE COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW (DHR) LOT# 4102146 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR INVESTIGATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR AND 2 BLOOD SAMPLING PORTS 84" TUBING DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT) THAT THE CUSTOMER REPORTED THE LINE DISCONNECTED. THE CUSTOMER REPORTED THE ANESTHESIA TECHNOLOGIST NOTICED THE LINE DISCONNECTED WHERE IT SHOULD BE BONDED TOGETHER. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233857 TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4102146 00840619041199

    Patients

    Seq Age Sex Outcome Treatment
    1