BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA APHERESIS SYSTEM

    MDR report key: 889996 · Received August 3, 2007

    Report

    Report Number
    1722028-2007-00002
    Event Type
    Death
    Date Received
    August 3, 2007
    Date of Event
    June 28, 2007
    Report Date
    August 2, 2007
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PERFORMED TO SPECIFICATION. RESULTS OF THE AUTOPSY CONCLUSION IS THAT THE CAUSE OF DEATH WAS RELATED TO THE CONDITION OF THE PT NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON JULY 2, 2007 THAT A PT HAD EXPIRED IN 2007. A THERAPEUTIC PLASMA EXCHANGE PROCEDURE WAS BEING PERFORMED ON A PT WITH THROMBOTIC THROMBOCYTOPENIA PURPURA. THE PROCEDURE WAS THE 8TH PROCEDURE AND THE PT WAS RESPONDING WELL. APPROX 85 MINS INTO THE PROCEDURE, THE PT WENT INTO RESPIRATORY DISTRESS AND EXPIRED. THERE WAS NO ALLEGATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE DEATH. THE FACILITY CONTACTED THE MANUFACTURER TO HAVE THE MACHINE CHECKED AS PRECAUTIONARY. THE MACHINE WAS INVESTIGATED THROUGH THE MANUFACTURER. THERE WAS NO MACHINE MALFUNCTION. THE TUBING SET USED ON THE MACHINE AT THE TIME OF THE EVENT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER, A REVIEW OF THE MANUFACTURING RECORDS DID NOT INDICATE ANY MANUFACTURING DEVIATIONS. AN AUTOPSY WAS PERFORMED TO DETERMINE THE CAUSE OF DEATH. RESULTS OF THE AUTOPSY REVEALED THAT THE PT HAD MULTIPLE DISEASES THAT WERE NOT SYMPTOMATIC. THE MEDICAL CONCLUSION WAS THAT THE DEATH WAS A RESULT OF THE MULTIPLE DISEASES AND NOT RELATED TO THE MANUFACTURER'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA APHERESIS SYSTEM APHERESIS SYSTEM LKN GAMBRO BCT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR