BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC PUMP CE ENGLISH

    MDR report key: 1001903 · Received February 21, 2008

    Report

    Report Number
    6000001-2008-00061
    Event Type
    Death
    Date Received
    February 21, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 5, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTEDLY, THE DEVICE WAS QUARANTINED AT THE INTERNATIONAL FACILITY AND THE FACILITY BIOMEDICAL ENGINEERING EVALUATED THE DEVICE. REPORTEDLY THE DEVICE PASSED ALL SAFETY CHECKS AND TESTS INCLUDING THE ACCURACY TEST. THE OVERDOSE OCCURRED, AND THERE WERE ALREADY MORE THAN 1000 ACTIVATIONS ON THE PUMP BY THE TIME THE HISTORY LOG WAS PRINTED, AND THEREFORE THE ACTUAL OVERDOSE EVENT WAS NOT AVAILABLE. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A PRODUCT COMPLAINT NOTIFICATION FORM AND BAXTER MEDICAL DEVICE FORM WERE RECEIVED FROM BAXTER ANOTHER COUNTRY ON 02/17/2008 INDICATING THAT A COLLEAGUE TRIPLE CHANNEL PUMP WAS ADMINISTERING PENICILLIN TO A PT ON THE MONTH BEFORE. THE LIKELY REASON WAS REPORTEDLY DUE TO DOSE ERROR BY THE NURSE. REPORTEDLY, THE WRONG DOSE WAS ADMINISTERED AND THE PT PASSED AWAY A FEW DAYS LATER. THE DOSE WAS REPORTEDLY SET AS MILLIGRAMS INSTEAD OF MICROGRAMS (1000 TIMES OVERDOSE). NO FURTHER INFO WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE TRIPLE CHANNEL VOLUMETRIC PUMP CE ENGLISH 80FRN FRN BAXTER HEALTHCARE PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death