BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 8214726 · Received January 3, 2019

    Report

    Report Number
    1314492-2018-05041
    Event Type
    Death
    Date Received
    January 3, 2019
    Date of Event
    December 5, 2018
    Report Date
    January 3, 2019
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K173084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. USE ERRORS, WARNINGS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿SPECTRUM OPERATOR MANUAL¿, WHICH IS SHIPPED WITH EVERY SPECTRUM DEVICE. THE MANUAL WARNS THAT OPERATION IS LIMITED TO BAXTER TRAINED OPERATORS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WAS TURNED OFF BY USER INPUT DURING THERAPY. LIFE SUPPORT CARE WAS BEING PROVIDED TO A PATIENT PREVIOUSLY DIAGNOSED AS BRAIN DEAD TO MAINTAIN THE CARDIOVASCULAR ACTIVITY AND BLOOD PRESSURE BY INFUSING NOREPINEPHRINE BITARTRATE AT AN UNREPORTED FLOW RATE. THE NOREPINEPHRINE BITARTRATE WAS USED TO KEEP THE PATIENT'S HEART PUMPING. THE PATIENT WAS BEING KEPT ALIVE UNTIL SOME OTHER FAMILY MEMBERS COULD ARRIVE THE NEXT DAY TO SAY GOODBYE. IT WAS REPORTED THAT THE HOSPITAL DID NOT HAVE THE KEYPAD AUTOLOCKING MECHANISM SET ON THE PUMP. A FAMILY MEMBER, WHO IS A PHYSICIAN, TURNED OFF THE PUMP. IT WAS ALSO ALLEGED BY A NURSE THAT THIS SAME FAMILY MEMBER TURNED OFF THE HEART MONITOR (THIS ALLEGATION IS NOT CONFIRMED). THE FAMILY MEMBER PHYSICIAN REPORTEDLY DETERMINED THAT THE PATIENT SHOULDN¿T BE KEPT ALIVE AND HE TOOK IT UPON HIMSELF TO ¿UNPLUG¿ THE PATIENT. THE PATIENT DIED WITHIN SECONDS OF THE PUMP BEING TURNED OFF. THE HOSPITAL REPORTED THIS AS A HOMICIDE TO THE POLICE. THE POLICE CURRENTLY HAVE THE PUMP IN THEIR CUSTODY AND TESTING OF THE PUMP OR EVALUATION OF THE PUMP¿S HISTORY LOG FILE BY BAXTER IS NOT POSSIBLE. IT WAS CONCLUDED THAT THE REPORTED EVENT OF DEATH IN AN ALREADY BRAIN-DEAD DIAGNOSED PATIENT IS NOT THE RESULT OF A POTENTIAL MALFUNCTION OF THE SPECTRUM PUMP, BUT RESULTED FROM A DELIBERATE SHUTOFF OF THE PUMP BY A FAMILY MEMBER OF THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7095 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death