BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMICUS APHERESIS KIT - CLSD SGL NDL

    MDR report key: 424037 · Received October 25, 2002

    Report

    Report Number
    1420141-2002-00059
    Event Type
    Death
    Date Received
    October 25, 2002
    Date of Event
    September 12, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 9/2002, A REPORT STATED THAT A PLATELET BAG FROM AN AMICUS KIT (LOT NUMBER N02D16014) HAD BEEN CULTURED AT THE HOSPITAL WHERE IT HAD BEEN USED FOR TRANSFUSION. THERE WAS GROWTH OF KLEBSIELLA PNEUMONIAE. NO GRAM STAIN WAS PERFORMED. THE TRANSFUSION OCCURRED IN 2002 FOR THE PATIENT HOSPITALIZED THAT DAY WITH A DIAGNOSIS OF NON-HODGKIN'S LYMPHOMA. THE PATIENT HAD A TRANSFUSIOON REACTION (DETAILS UNKNOWN) AND BLOOD CULTURES WERE POSITIVE FOR KLEBSIELLA PNEUMONIAE ACCORDING TO A REPORT FROM THE DONOR CENTER RECEIVED ON 10/09/2002. THIS REPORT STATED THE DONOR RETENTION TUBE WAS NEGATIVE. BLOOD CULTURES WERE NEGATIVE FOR KLEBSIELLA PNEUMONIAE BY 09/2002 BUT THE PATIENT REMAINED SEPTIC WITH DIFFERENT ORGANISMS, NOT IDENTIFIED TO THE MANUFACTURER. BLOOD CULTURES IN 10/2002 AND SHOWED NO GROWTH. AN ABDOMINAL ULTRASOUND PERFORMED IN 09/2002 TO INVESTIGATE THE PATIENT'S LIVER FAILURE SHOWED NO MASSES IN THE LIVER AND EARLIER CT SCAN IN AUGUST 2002 FOR STAGING THEIR LYMPHOMA SHOWED NO EVIDENCE OF AN ABDOMINAL OR THORACIC ABSCESS. THE PATIENT WAS INTUBATED THROUGHOUT MOST OF THEIR HOSPITALIZATION. IN 10/2002, THE PATIENT BECAME SEVERELY HYPOTENSIVE, POSSIBLY DUE TO SEPSIS. THE PATIENT WAS DNR (DO NOT RESUSCITATE) SO NO BLOOD CULTURES WERE DRAWN AT THAT TIME. THE PATIENT EXPIRED IN 2002. NO IMMEDIATE CAUSE OF DEATH WAS GIVEN AND AN AUTOPSY WAS NOT REQUESTED. THE PATIENT HAD BEEN MEDICATED WITH LANOXIN PRIOR TO THE ADVERSE EVENT AND RECEIVED DOPAMINE, VANCOMYCIN, TOBRAMYCIN, MAXIPINE, LEVAQUIN, BENADRYL, SOLUMEDROL, O2 PER NASAL CANULA, NORMAL SALINE AND WAS INTUBATED AS A RESULT OF THE EVENT. THE PLATELET BAG HAD BEEN STORED BY THE DONOR CENTER FOR 3 DAYS AT ROOM TEMPERATURE AND WAS INSPECTED PRIOR TO ITS RELEASE TO THE HOSPITAL IN 2002. THE INSPECTION AT THE TIME OF RELEASED REVEALED NO APPARENT ABNOMALITIES. A VERBAL REPORT TO THE FDA ON 10/16/2002 FROM THE HOSPITAL STATED THAT THE PLATELET TRANSFUSION IN 2002 MAY HAVE INITIATED THE COURSE THAT LEAD TO, BUT WAS NOT THE CAUSE OF, THE PATIENT DEATH. THE DONOR WAS AN INDIVIDUAL WITH A SATISFACTORY HEALTH HISTORY, RECEIVING NO MEDICATIONS AND HAD NO SYMPTOMS OF INFECTION. A FOLLOW UP CALL TO THE DONOR IN 09/2002 BY THE CENTER REVEALED NO HEALTH PROBLEMS WITH THE DONOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMICUS APHERESIS KIT - CLSD SGL NDL AMICUS GKT BAXTER HEALTHCARE CORP. NA N02D16014

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death