BEUDAMED
    FDA Adverse Event Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 3183063 · Received June 21, 2013

    Report

    Report Number
    1722028-2013-01257
    Date Received
    June 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 24, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK020041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE TERUMO BCT SUPPORT SPECIALIST DISCUSSED WITH THE NURSE THAT WITH RBCX PROCEDURE THEY CAN SEE A 40-60% DROP IN THE PATIENT PLATELET COUNT. THE NURSE STATED THEY DO NOT THINK THAT THE DROP IN PLATELET COUNT PRE TO POST PROCEDURE ON EACH OF THE PROCEDURES WAS THE CAUSE OF THE HEMORRHAGE AS IT OCCURRED 4 DAYS POST PROCEDURE AND THE PLATELET COUNT HAD REBOUNDED TO 355X10^3. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THIS LOT. THERE WERE NO ISSUES NOTED IN THE DHR THAT WOULD HAVE CONTRIBUTED TO THE PATIENT DEATH. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER COULD NOT PROVIDE A MEDICAL RECORD NUMBER OR A COPY OF THE DISCHARGE SUMMARY FOR THIS PATIENT, BUT SHE WAS WILLING TO SUMMARIZE IT OVER THE PHONE. THE DISCHARGE SUMMARY STATED THAT THE PATIENT DIED DUE TO SICKLE CELL DISEASE, BILATERAL INTRAPARENCHYMAL CEREBRAL HEMORRHAGE AND MALIGNANT CEREBRAL EDEMA. THE COBE SPECTRA SYSTEM WAS NOT IMPLICATED IN THE PATIENT'S DEATH. A SERVICE CALL WAS PLACED FOR THE MACHINE. A FUNCTIONAL CHECKOUT OF THE DEVICE WAS PERFORMED. ALL SYSTEMS PASSED THE TESTING AND NO ITEMS WERE FOUND TO BE OUTSIDE OF THE MACHINE SPECIFICATIONS. A SIMULATED RUN WAS COMPLETED AND NO PROBLEMS WERE NOTED. ROOT CAUSE: BASED ON THE DEVICE CHECKOUT, THE CUSTOMER'S EVALUATION OF THE PATIENT'S CONDITION AND THE FACT THAT THE PATIENT'S PLATELET COUNTS REBOUNDED POST BOTH PROCEDURES, THE CAUSE OF THE PATIENT'S DEATH WAS THE PATIENT'S DISEASE STATE.

    Description of Event or Problem · 1

    A TERUMO BCT PRODUCT SPECIALIST WAS AT THE CUSTOMER SITE WHEN SHE WAS MADE AWARE OF A PATIENT DEATH THAT OCCURRED FOLLOWING A RED BLOOD CELL EXCHANGE (RBCX) PROCEDURE. THE PATIENT WAS AN INPATIENT AT THE HOSPITAL AND INITIALLY UNDERWENT A RBCX ON (B)(6) 2013 FOR ACUTE CHEST CRISIS. HE TOLERATED THE PROCEDURE WELL AND WAS IMPROVING. ON (B)(6) 2013 THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013 HE WAS BROUGHT IN TO THE EMERGENCY ROOM BY AMBULANCE WITH PROJECTILE VOMITING, HEADACHE, PHOTOPHOBIA AND A REPORT THAT HE HAD HAD A SEIZURE. HE BECAME UNRESPONSIVE. A HEAD CT WAS DONE AND IT SHOWED BILATERAL SUBARACHNOID HEMORRHAGES. HE WAS ADMITTED TO THE INTENSIVE CARE UNIT. HIS RESPIRATORY STATUS DECOMPENSATED AND HE WAS INTUBATED AND PLACED ON A VENTILATOR. ON (B)(6) 2013 THEY PERFORMED A SECOND RBCX PROCEDURE WHICH THE NURSE STATED WAS DUE TO HIS RESPIRATORY STATUS. HE WAS STILL ON THE VENTILATOR AND WAS UNRESPONSIVE TO COMMANDS AT THIS TIME AND HAD BEEN SINCE ADMISSION TO THE ICU. THE RBCX PROCEDURE WAS REPORTED TO BE UNEVENTFUL. HE CONTINUED TO DETERIORATE FROM A MENTAL STATUS PERSPECTIVE OVER THE NEXT SEVERAL DAYS AND ON (B)(6) 2013 IT WAS NOTED THAT HE HAD CEREBRAL EDEMA AND CSF DRAINAGE. AN EEG WAS PERFORMED AND REPORTED THAT THERE WAS NO CEREBRAL BLOOD FLOW AND THE PATIENT HAD BRAIN DEATH. THE PATIENT EXPIRED ON (B)(6) 2013. THE PATIENT WEIGHT IS NOT AVAILABLE PER THE CUSTOMER. THE DISPOSABLE SETS ARE NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED THEM. THIS REPORT IS BEING FILED DUE TO A PATIENT DEATH, THOUGH AT THIS TIME, NEITHER THE MACHINE NOR DISPOSABLE IS NOT IMPLICATED IN THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282480 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA RBCX SET GKT TERUMO BCT 11U15239

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Hospitalization