BEUDAMED
    FDA Adverse Event Death Summary report: N

    JMS A.V. FISTULA NEEDLE SET

    MDR report key: 134918 · Received November 26, 1997

    Report

    Report Number
    134918
    Event Type
    Death
    Date Received
    November 26, 1997
    Date of Event
    November 18, 1997
    Report Date
    November 26, 1997
    Manufacturer
    JMS CO. LTD.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 19 NOVEMBER 1997, THE CTR DIRECTOR OF THE PLASMAPHERESIS CTR REC'D A CALL FROM HLTH DEPT THAT DONOR WAS DECEASED ON 18 NOVEMBER 1997. THE DONOR'S ROOMMATE TOLD THE HLTH DEPT STAFF THAT THE DONOR HAD GASTROINTESTINAL DISTRESS ON 15 NOVEMBER 1997, SOMETIME AFTER HIS DONATION. THE ROOMMATE OF THE DONOR STATED THAT THEY HAD EATEN GROUND BEEF AND MACARONI AND CHEESE FOR DINNER ON 15 NOVEMBER 1997. THE ROOMMATE AND HIS DAUGHTER ALSO EXPERIENCED GASTROINTESTINAL DISTRESS (NAUSEA, VOMITING AND DIARRHEA). ON 17 NOVEMBER, THE ROOMMATE TOOK THE DONOR TO HOSP ER FOR CONTINUING DIARRHEA AND VOMITING. THE DONOR WAS OBSERVED IN THE ER AND RELEASED WITH A DIAGNOSIS OF STOMACH FLU. THE DONOR MAY HAVE BEEN PRESCRIBED MEDICATION BY THE ER PHYSICIAN. THIS HAS NOT YET BEEN CONFIRMED. ON 18 NOVEMBER, THE DONOR WAS FOUND DECEASED ON THE FLOOR OF THEIR HOME BY HIS ROOMMATE. THE DONOR'S LAST DONATION OCCURRD ON 15 NOVEMBER 1997. THE MOST RECENT PHYSICAL EXAMINATION DATE WAS 02 OCTOBER 1997. A REVIEW OF THE DONOR RECORD FILE WAS DONE. THERE WERE NO UNUSUAL OR ABNORMAL FINDINGS. THE DONOR WAS A THIRTY-THREE YR OLD CAUCASIAN MALE. AN AUTOPSY WAS PERFORMED 20 NOVEMBER 1997. THE AUTOPSY REVEALED NO OBVIOUS CAUSE OF DEATH. TOXICOLOGY, MICROBIOLOGY AND CHESMISTRY TESTS ARE BEING PERFORMED. PRELIMINARY RESULTS REPORTED 21 NOVEMBER 1997 FOR THE MICROBIOLOGY CULTURES WERE NEGATIVE. FINAL RESULTS ARE NOT EXPECTED FOR FOUR TO SIX WEEKS. ALL LOT NUMBERS OF SUPPLIES UTILIZED DURING THE PLASMAPHERESIS PROCEDURE FOR THIS DONOR ON 15 NOVEMBER 1997 WERE IDENTIFIED. CERTIFICATES OF COMPLIANCE ARE AVAILABLE AT THE DONOR CTR FOR THE SOFTGOODS UTILIZED IN THE PROCEDURE. THE MFRS OF THESE SUPPLIES WERE NOTIFIED OF THIS DONORS DEATH ON 24 NOVEMBER 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JMS A.V. FISTULA NEEDLE SET APHERESIS NEEDLE GKT JMS CO. LTD. NA 970702601

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death| H 1. PLASMA POOLING BOTTLE.| 2. PLASMAPHERESIS BOWL AND APHERESIS NEEDLE.