BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSPIRA

    MDR report key: 1960936 · Received January 11, 2011

    Report

    Report Number
    MW5018952
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    HOSPIRA
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SECOND BOTTLE OF INTEGRILIN WAS HUNG. RATE WAS SET AT 15 CC/HR & VTBI WAS SET FOR 75CC. CONTROL KNOB MALFUNCTIONED CAUSING PUMP NOT TO SWITCH BETWEEN RATE & VTBI. WHEN KNOB WAS TURNED TO RUN, THE RATE WAS CHANGED TO 75 CC/HR. THE PROBLEM WAS IDENTIFIED AFTER 3/4 BOTTLE HAD INFUSED IN LESS THAN AN HOUR. WITNESS VERIFIED THAT WHEN VTBI WAS CHANGED, THE RATE CHANGED AS WELL. PUMP WAS TAKEN OUT OF SERVICE, BIOMED & PHYSICIAN WERE NOTIFIED. DIAGNOSIS FOR USE: STENTS X 3 TO LAD. APPROX AGE OF DEVICE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA SINGLE CHAMBER INFUSION PUMP FRN HOSPIRA PLUM XL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other INTEGRILIN, 15 CC/HR IV X 2 BOTTLES