BEUDAMED
    FDA Adverse Event Death Summary report: N

    BODYGUARD

    MDR report key: 882571 · Received July 18, 2007

    Report

    Report Number
    3004146070-2007-00001
    Event Type
    Death
    Date Received
    July 18, 2007
    Date of Event
    June 26, 2007
    Report Date
    July 17, 2007
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY BELIEVES THE OVER-DELIVERY WAS RELATED TO A PROGRAMMING CHANGE, WHILE THE PUMP WAS IN THE HOSPICE. THE HOMECARE PROVIDER PHARMACIST PREPARED THE MEDICATION BAG AND PROGRAMMED THE PUMP WITH THE PT'S INFUSION PARAMETERS. THE SETTING WERE CONFIRMED OK BY THE HOMECARE PROVIDER'S NURSE. THE HOMECARE PROVIDER'S NURSE CALLED THE HOSPICE NURSE TO CHECK ON THE STATUS OF THE PUMP AND PT. EVERYTHING WAS REPORTED AS BEING FINE: PT WAS COMFORTABLE AND HER VITAL SIGNS WERE NORMAL. ON THE MORNING OF THE FOLLOWING DAY, WHEN THE BAG WAS FOUND EMPTY, A TELEPHONE REVIEW OF THE PROGRAMMED SETTINGS ESTABLISHED THAT THE CONCENTRATION HAD BEEN CHANGED TO 0.2 MG/ML INSTEAD OF 5 MG/ML BY SOMEONE AT THE PT'S HOME. THE HOSPICE NURSE CONFIRMED THAT NO DEMAND BOLUSES HAD BEEN GIVEN SINCE THE BEGINNING OF THERAPY. IT IS UNKNOWN IF THE ORAL AND RECTAL MEDS WERE DISCONTINUED WHEN THE SQ PAIN MANAGEMENT STARTED. MFR HAS ATTEMPTED TO ACQUIRE THE ACTUAL DEVICE, BUT HAS LEARNED FROM THE USER FACILITY THAT IT IS BEING SENT TO AN INDEPENDENT LAB FOR EVALUATION. MFR IS ATTEMPTING TO WORK WITH THE INDEPENDENT LAB IN ORDER TO DOWNLOAD HISTORICAL EVENTS RELATED TO THE PT'S INFUSION THERAPY REGIMEN.

    Description of Event or Problem · 1

    (THE MANUFACTURER OF BODYGUARD 323 PUMPS) HAS FILED THIS REPORT AFTER BECOMING AWARE OF A REPORTABLE EVENT THRU THE MANUFACTURER'S DISTRIBUTOR. A PATIENT WITH A DIAGNOSIS OF MALIGNANT MELANOMA WITH METASTASIS WAS ADMITTED TO A LOCAL HOSPICE SERVICE. THE PT WAS CONNECTED SUBCUTANEOUSLY TO A BODYGUARD 323 PUMP FOR PAIN RELIEF INFUSION (MORPHINE) MEDICATION. TWO DAYS LATER AT 4:30 AM, HOSPICE NURSE CALLED ON-CALL NURSE AT THE HOMECARE COMPANY (WHO WAS THE PROVIDER OF THE PUMP AND MEDICATION) TO ANNOUNCE THAT MEDICATION BAG WAS EMPTY, ALTHOUGH, IT WAS SUPPOSED TO LAST 1000 HOURS. AT THAT TIME, THE PT'S VITAL SIGNS WERE CHECKED AND FOUND TO BE OK: RESPIRATORY RATE WAS 30, BLOOD PRESSURE WAS NORMAL FOR THIS PT, AND PULSE WAS FINE. AS A PRECAUTIONARY MEASURE THE PT WAS TAKEN TO THE HOSPITAL, ADMINISTRATED A DOSE OF NALOXONE (MORPHINE ANTAGONIST) AND ADMITTED FOR OBSERVATION. LATER THAT AFTERNOON, AFTER MORE THAN 12 HOURS, THE PT PASSED AWAY, SPECULATED TO BE FROM NATURAL CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODYGUARD INFUSION PUMP MEA CAESAREA MEDICAL ELECTRONICS LTD. 323 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death DISPOSABLE RESERVOIR BAG| DISPOSABLE ADMINISTRATION SET