BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 4156908 · Received October 9, 2014

    Report

    Report Number
    1722028-2014-00404
    Event Type
    Death
    Date Received
    October 9, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK080035
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RETURNED FOR INVESTIGATION. THE SET WAS VISUALLY INSPECTED FOR MISSING PARTS, MIS-ASSEMBLY, KINKS, OCCLUSIONS AND OTHER DEFECTS, NONE WERE FOUND. THE MACHINE WAS CHECKED OUT AT THE CUSTOMER SITE BY A TERUMO BCT SERVICE TECHNICIAN. ALL VOLTAGES, PRESSURES, PUMPS AND PUMP OCCLUSIONS, CENTRIFUGE, VALVES, RED BLOOD CELL DETECTOR AND CONTROL MONITOR WERE FUNCTIONALLY CHECKED AND FOUND TO BE WITHIN MANUFACTURER'S SPECIFICATIONS. THE MACHINE WAS CONFIRMED TO BE OPERATING AS INTENDED AND WAS RELEASED FOR USE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY IN THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION TO ALIGN WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. BASED ON INFORMATION PROVIDED BY THE CUSTOMER, THE PATIENT WAS BEING TREATED IN THE INTENSIVE CARE UNIT AT THE REQUEST OF THE PHYSICIAN, WITH THE PROCEDURE BEING CARRIED OUT TO GIVE THE PATIENT THE BEST CHANCE OF SURVIVAL. THE ASSOCIATED PHYSICIAN STATED THAT THE PATIENT¿S DEATH IS NOT CONTRIBUTED TO THE APHERESIS PROCEDURE. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT AND NONE HAVE BEEN REPORTED. ROOT CAUSE: NO FAULTS WERE FOUND WITH THE DISPOSABLE SET OR THE MACHINE. PROVIDED BY THE CUSTOMER, CAUSE OF PATIENT¿S CONDITION WAS DUE TO THE PATIENT BEING CRITICALLY ILL SUFFERING FROM THROMBOTIC THROMBOCYTOPENIC PURPURA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A THERAPEUTIC PLASMA EXCHANGE (TPE)PROCEDURE AND SHE HAD A RESPIRATORY EVENT THAT LEAD TO HER EXPIRATION. APPROXIMATELY 10 MINUTES INTO THE PROCEDURE, THE PATIENT WENT INTO RESPIRATORY ARREST. SHE WAS TURNED ON HER SIDE, THE PROCEDURE WAS ENDED, AND A CODE WAS CALLED. THE PATIENT LATER EXPIRED. THE CUSTOMER IS NOT ALLEGING A DEFICIENCY WITH THE DISPOSABLE SET OR DEVICE. PER THE PATIENT'S PHYSICIAN, THE ACUITY OF THE PATIENT'S DISEASE STATE WAS THE CAUSE OF PATIENT EXPIRATION. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, THOUGH AT THIS TIME IT IS NOT SUSPECTED OR ALLEGED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634663 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA TPE SET GKT TERUMO BCT 07W15275

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR