BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CE INFUSOR LV 2, 12 PACK

    MDR report key: 1083318 · Received July 28, 2008

    Report

    Report Number
    6000001-2008-00436
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEB
    PMA / PMN Number
    K905778
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IN 2008, BAXTER REC'D A REPORT THAT A 5 DAY INFUSOR 2C1008KP, LOT 08C033, HAD RUN EMPTY WITHIN 24 HRS INSTEAD OF 5 DAYS. THE CUSTOMER IS EVALUATING INTERNALLY IF ANY USER ERROR MIGHT HAVE CAUSED THE EVENT AND WOULD LIKE TO PROVIDE MORE INFO ONLY WHEN THE RESULT IS KNOWN. THE MALE PATIENT'S OUTCOME WAS THAT HE FELL INTO COMA FROM 12:00 UNTIL 18:00 ON THE SAME DAY. HE RECOVERED AND SHOWED NO CLINICAL CONSEQUENCES OF THE OVERINFUSION. THE PT SUFFERED FROM A HIGH TEMPERATURE, BUT THE RELATIONSHIP IS NOT CLEAR FOR THIS. THE PATIENT'S MEDICAL HISTORY INCLUDES CANCER AND HE IS CURRENTLY HOSPITALIZED, NOT DUE TO THE INCIDENT, BUT DUE TO HIS TERMINAL STAGE. HE IS EXPECTED TO DIE SOON. THE PT RECEIVES HIGH DOSES OF METHADONE. THE THERAPY ADMINISTERED WITH THE INFUSOR WAS A PALLIATIVE THERAPY. THE FILL VOLUME OF 240 IS NOT VERIFIED; IT COULD HAVE BEEN ONLY 70 ML INSTEAD OF 240 ML. THE DRUGS FILLED WERE: 400 MG METHADONE (40 VIALS KETALGIN 10 MG/1ML), 750 MG CHLORPROMAZINE (15 VIALS CHLORAZINE 50 MG/2ML), AND NACI 0.9% 170 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 2, 12 PACK 80MEB MEB BAXTER HEALTHCARE CORP. 08C033

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention