BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PRI TUBING

    MDR report key: 10299876 · Received July 20, 2020

    Report

    Report Number
    9616066-2020-02277
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 29, 2020
    Report Date
    June 30, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    LHI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD PRI TUBING EXPERIENCED CONCURRENT FLOW/SIMULTANEOUS FLOW (UNDERINFUSION). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN RN DESCRIBED GOING IN TO HANG THE NEXT DOSE OF UNASYN AND FINDING A BULGING BAG OF UNASYN STILL HANGING. I SEE THE UNASYN STARTING, THEN THE MIV TRANSITIONING (I ASSUME WHEN VOLUME TO BE INFUSED IS COMPLETED FOR UNASYN); THEN I ASSUME THE UNASYN AS PRIMARY IV/TRANSITIONING IS JUST DESCRIBING THE SWITCH BACK TO THE MIV FLUID. I AM NOT AWARE OF ANYWHERE IN THE REPORT WHERE YOU COULD SEE IF THE IV SECONDARY WAS PROGRAMMED CORRECTLY, BUT NEVER INFUSED. MY BEST GUESS IS MAYBE THEY FORGOT TO UNCLAMP THE IVPB?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764060 UNSPECIFIED BD PRI TUBING TUBING SET LHI SISTEMAS MEDICOS ALARIS, S.A. DE C. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other