BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE SPECTRA APHERESIS SYSTEM

    MDR report key: 727737 · Received June 13, 2006

    Report

    Report Number
    727737
    Event Type
    Death
    Date Received
    June 13, 2006
    Date of Event
    February 22, 2006
    Report Date
    May 30, 2006
    Manufacturer
    GAMBRO BCT, INC
    Product Code
    LKN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED FOR MULTIPLE MEDICALPROBLEMS INCLUDING MICROANGIOGRAPHIC ANEMIA WITH DECREASED PLATELETS, ABNORMAL RENAL FUNCTION AND HIGH LDH. THE WORKING DIAGNOSIS WAS THROMBOTIC THROMBOCYTOPENIA PURPURA (TTP). SHE WAS STARTED ON HIGH -DOSE STEROIDS AND DAILY PLASMAPHERESIS TREATMENTS. AFTER SEVERAL DAYS OF TREATMENTS, THE PATIENT'S NEUROLOGICAL STATUS SHOWED SOME IMPROVEMENT BUT SHE REMAINED SOMNOLENT AND MINIMALLY RESPONSIVE TO COMMANDS, HER LAB VALUES (PRIMARILY LDH AND PLATELETS) DID NOT SHOW IMPROVEMENT. AFTER THE FIFTH PLASMAPHERESIS TREATMENT, THE RN NOTED THE PATIENT TO BE RESTLESS AND SHORT OF BREATH, AND ALSO NOTICED THAT THE WASTE PLASMA BAG WAS ALMOST EMPTY. THE MACHINE HAD APPARENTLY MALFUNCTIONED CAUSEING THE WASTE PLASMA TO BE CYCLED BACK INTO THE PATIENT INSTEAD OF INTO THE WASTE BAG. THE PATIENT HAD RECEIVED A FLUID OVERLOAD OF APPROXIMATELY 2 LITERS. SHE WAS TREATED WITH LASIX TO INCREASE URINE OUTPUT TO CORRECT THE FLUID IMBALANCE. ON DAY 2 AFTER THE FLUID OVERLOAD EVENT THE PATIENT BECAME BRADYCARDIC AND PULSELESS, AND EXPIRED . THE MACHINE WAS REMOVED FROM SERVICE, TESTED AND FOUND TO WORKING PROPERLY. IT WAS SUBSEQUENTLY RETURNED TO SERVICE BUT ADDITIONAL PROBLEMS OCCURRED AND THE MACHINE WAS PERMANENTLY TAKEN OUT OF SERVICE. IT WAS APPROXIMATELY 15 YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM APHERESIS/THERAPEUTIC PLASMA EXCHANGE LKN GAMBRO BCT, INC SPECTRA (TUBING) 01M15263

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| L| R W/-WITH