BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLASMACELL-C DISPOSABLE KIT W/ ATTACHED FISTULA

    MDR report key: 1523165 · Received October 29, 2009

    Report

    Report Number
    3004548776-2009-00004
    Event Type
    Death
    Date Received
    October 29, 2009
    Date of Event
    September 24, 2009
    Report Date
    October 1, 2009
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    PMA / PMN Number
    BP850001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE KIT WAS NOT AVAILABLE FOR TESTING. ALL RELATED COMPONENTS WERE SUBMITTED, AS PART OF THE DEATH INVESTIGATION, THUS PRECLUDING ANALYSIS BY THE MANUFACTURER. TWO BAGS OF ANTICOAGULANT HAD BEEN RECOVERED. INFORMATION RECEIVED INDICATED THAT THE OPERATOR USED THE WRONG SOLUTION FOR RE-INFUSION. A REVIEW OF THE COMPLAINT HISTORY FOR AUTO-C REVEALED NO SIMILAR INCIDENTS RELATED TO THE REPORTED ISSUE. A BATCH REVIEW FOR AUTO-C KIT, D4R2208P, LOT FA09C24195 REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. THERE WAS NO INDICATION OF DEVICE OR KIT FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM ANOTHER COUNTRY, INDICATING A PATIENT'S DEATH RELATED TO USER ERROR. A FEMALE WAS DONATING PLASMA IN 2009 AT A HOSPITAL. ACCORDING TO REPORTS, THE DONOR EXPERIENCED CARDIAC ARREST NEAR THE END OF THE DONATION PROCEDURE. THE DONOR FIRST HAD SIGNS OF TETANY APPROXIMATELY 2 MINUTES AFTER THE END OF A PLASMA COLLECTION WHEN SODIUM CHLORIDE WOULD BE RE-INFUSED. THE DONOR LOST CONSCIOUSNESS AND SHOWED "ASYSTOLE". THE DONOR WAS IMMEDIATELY DISCONNECTED FROM THE KIT. THE NEEDLE WAS REMOVED BECAUSE OF FLEXION OF THE ARMS AND NO CALCIUM WAS INJECTED. THE DONOR WAS "RE-ANIMATED" FIRST BY THE MEDICAL TEAM, THEN BY THE EMERGENCY UNIT WHICH ARRIVED WITHIN "15'" (MINUTES) FROM THE INCIDENT. HEART RE-STARTED AFTER 15' (MINUTES) BUT THE DONOR STAYED IN A COMA FOR A FEW DAYS UNTIL HER DEATH FIVE DAYS LATER. THE AUTO-C DEVICE HAD BEEN TURNED OFF WHEN THE EVENT OCCURRED; THEREFORE, DATA FROM THE DEVICE WAS NOT AVAILABLE. THERE WAS NOTHING ABNORMAL REPORTED DURING THE COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMACELL-C DISPOSABLE KIT W/ ATTACHED FISTULA APHERESIS DISPOSABLES GKT FENWAL, INC. NA FA09C24195

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death ANTICOAGULANT AB 16, MANUFACTURER AND LOT UNKNOWN.| SALINE SOLUTION, MANUFACTURER AND LOT UNKNOWN.| MANUFACTURED BY FENWAL.| AUTO-C INSTRUMENT