BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY MICROBORE GEMSTAR SET WITH 0.2MICRON FILTER

    MDR report key: 2362747 · Received December 1, 2011

    Report

    Report Number
    MW5023335
    Event Type
    Injury
    Date Received
    December 1, 2011
    Date of Event
    November 24, 2011
    Report Date
    December 1, 2011
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE HAVE HAD TWO PATIENTS ON CONTINUOUS IV PIPERCILLIN TAZOBACTAM ON A HOSPIRA GEMSTAR PUMP. ON THREE OCCASIONS IN THE LAST TWO WEEKS, I HAVE HAD PATIENTS CALL COMPLAINING OF AN OCCLUSION ALARM. AFTER SWITCHING INFUSION TUBING THE OCCLUSION ALARM GOES AWAY TELLING ME WE ARE MOST LIKELY HAVING DRUG PRECIPITATE IN THE FILTER CAUSING AND OCCLUSION. DOSE: 18GM OVER 24 HOURS. DATES OF USE: (B)(6) 2011 TO PRESENT. REASON FOR USE: DIABETIC FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY MICROBORE GEMSTAR SET WITH 0.2MICRON FILTER GEMSTAR 0.2 MICRON SET FPA 13759-28 07175 5H

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR PIPERACILLIN TAZOBACTAM 40.5GM BULK,| LOT 503B5020, EXP DATE 07/2013| APOTEX CORP/HOSPIRA