BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE MULTITHERAPY INFUSION PUMP KIT

    MDR report key: 3901573 · Received June 20, 2014

    Report

    Report Number
    3901573
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 18, 2014
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SAPPHIRE PCA ON ICU PT WITH DILAUDID .2 MG/DL IN A 100 ML BAG. PUMP SET AT CONTINUOUS RATE OF .5 MG/HR WITH A BOLUS DOSE OF .5 MG AVAILABLE UP TO 4 TIMES PER HR. A NEW BAG WAS HUNG AT 0320 HR. RN FOUND BAG EMPTY AT 1500 HR. IN THE <12 HR TIME, THE CALCULATED VOLUME THAT SHOULD HAVE BEEN DELIVERED DURING THIS TIME PERIOD WAS 72.5 ML (CONTINUOUS PLUS 17 BOLUS DOSES) WITH 27.5 ML REMAINING. HOWEVER, ACCORDING TO THE PUMP READING THERE SHOULD HAVE BEEN 42.6ML LEFT IN THE BAG. THE PT REC'D A HIGHER DOSE THAN PLANNED BUT THERE WAS NO SIGNIFICANT ADVERSE IMPACT TO PT. THE DEVICE IS DISTRIBUTED BY HOSPIRA, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363431 SAPPHIRE MULTITHERAPY INFUSION PUMP KIT PCA INFUSION PUMP MEA Q CORE MEDICAL LTD 16365-04-01

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other