BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIMA EXCEL LRS PLAT, PLAS, RBC BLOOD TUBING SET

    MDR report key: 992066 · Received November 15, 2007

    Report

    Report Number
    1722028-2007-00003
    Event Type
    Death
    Date Received
    November 15, 2007
    Date of Event
    October 8, 2007
    Report Date
    November 15, 2007
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET INVOLVED IN THE INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION BY THE MANUFACTURER, HOWEVER, ALL MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER WERE REVIEWED. THE REVIEW OF THE RECORDS CONCLUDED THAT THE REPORTED LOT WAS MANUFACTURED TO SPECIFICATION. THE MACHINE USED TO RUN THE TUBING SET IS MANUFACTURED BY THE SAME MANUFACTURER OF THE BLOOD TUBING SET. ALTHOUGH IT IS HIGHLY UNLIKELY THE MACHINE WOULD HAVE BEEN A CONTRIBUTING FACTOR TO THIS INCIDENT, THE MACHINE WAS EVALUATED BY THE MANUFACTURER SERVICE. THE RESULTS OF THE EVALUATION CONCLUDED THAT THE MACHINE PERFORMED TO SPECIFICATION. THE MANUFACTURER'S STERILIZATION PROCESS FOR THE BLOOD TUBING SET USES ETO (ETHLENE OXIDE. STAPHYLOCOCCUS AUREUS IS A NORMAL FLORA OF THE SKIN. STAPHYLOCOCCUS AUREUS IS NOT RESISTANT TO ETHLENE OXIDE (ETO) STERILIZATION, THEREFORE, STAPHYLOCOCCUS AUREUS WOULD NOT BE A BACTERIAL CONTAMINATION PRESENT IN THE BLOOD TUBING SET POST STERILIZATION PROCESS FOR THE LOT. A REVIEW OF THE STERILIZATION RECORDS FOR THE REPORTED LOT INDICATED THE TUBING SET WAS STERILIZED TO SPECIFICATION WITH NO DEVIATIONS. THROUGH THE INVESTIGATION BY THE MANUFACTURER IT HAS BEEN CONCLUDED THAT THE REPORTED INCIDENT WAS NOT CAUSED BY THE MANUFACTURER'S DEVICE, AND THE DEVICE DID CONTRIBUTE TO THE INCIDENT.

    Description of Event or Problem · 1

    A FEMALE PATIENT WITH H/O PULMONARY EMBOLI DEVELOPED RIGORS, NAUSEA AND CHILLS AFTER APPROXIMATELY FIVE MINUTES OF THE START OF A PLATELET TRANSFUSION. THE TRANSFUSION WAS STOPPED (THE PATIENT RECEIVED ONLY 5 ML OF PLATELET PRODUCT, WHICH HAD BEEN COLLECTED FROM A DONOR USING THE MANUFACTURERS BLOOD TUBING SET). THE PATIENT EXPIRED APPROXIMATELY 26 HOURS LATER. SAMPLES WERE TAKEN FROM BOTH THE PATIENT AND THE PLATELET PRODUCT AND BOTH TESTED POSITIVE FOR STAPHYLOCOCCUS AUREUS, A NORMAL FLORA OF THE SKIN. THERE WAS NO ALLEGATION FROM THE FACILITIES HEALTHCARE PROFESSIONAL THAT THE MANUFACTURER'S TUBING SET CAUSED OR CONTRIBUTED TO THE DEATH. THE FACILITY IS TREATING THIS INCIDENT AS A SEPTIC TRANSFUSION REACTION FROM A CONTAMINATED PLATELET PRODUCT. TO DATE, NO INFORMATION HAS BEEN PROVIDED, WHETHER AN AUTOPSY WAS PERFORMED, HOWEVER, THE FACILITY DID PROVIDE A PRELIMINARY PATHOLOGY OF THE PATIENT, WHICH IS LISTED IN SECTION 7 OF THIS MEDWATCH FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA EXCEL LRS PLAT, PLAS, RBC BLOOD TUBING SET APHERESIS SYSTEM LKN GAMBRO BCT, INC. NA 07N3126

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR