BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 4997060 · Received August 12, 2015

    Report

    Report Number
    1419106-2015-00203
    Event Type
    Death
    Date Received
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN WHEN THE PATIENT RECEIVED THE CONTAMINATED CALCIUM GLUCONATE INFUSION BUT WAS REPORTED TO BE "ON OR ABOUT (B)(4) 2013". A SAMPLE WAS NOT RETURNED FOR EVALUATION AND SINCE THE LOT NUMBER WAS NOT PROVIDED, A BATCH REVIEW COULD NOT BE PERFORMED. THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED AFTER RECEIVING A BACTERIA CONTAMINATED SOLUTION CONTAINED IN AN UNKNOWN BAXTER BAG. THE PATIENT HAD BEEN ADMINISTERED A COMPOUNDED SOLUTION CONTAINING CALCIUM GLUCONATE AND IT WAS ALLEGED THAT THE BAG MAY HAVE BEEN CONTAMINATED WITH BACTERIA. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527853 NI CONTAINER, I.V. KPE BAXTER HEALTHCARE CORPORATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CALCIUM GLUCONATE