BEUDAMED
    FDA Adverse Event Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 3140316 · Received May 31, 2013

    Report

    Report Number
    1722028-2013-01231
    Date Received
    May 31, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    K893962
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A PRODUCT DISPOSITION FORM (PDF) REVIEW WAS COMPLETED FOR THIS MACHINE SERIAL NUMBER AND NO MANUFACTURING RELATED ISSUES WERE FOUND. UPON FOLLOW-UP TO CLARIFY THE "PATIENT COMPLICATIONS" REPORTED BY THE CUSTOMER, THE CUSTOMER REPLIED ON (B)(6) 2013 THAT THE PATIENT EXPIRED SEVERAL HOURS FOLLOWING THE PROCEDURE, BUT THAT THEY DID NOT BELIEVE THE MACHINE WAS INVOLVED. SHE STATED IT IS THEIR POLICY TO HAVE A DEVICE EVALUATED FOLLOWING A PATIENT DEATH. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED; BASED ON THE DEVICE CHECKOUT FINDINGS AND INFORMATION PROVIDED BY THE CUSTOMER, THE CAUSE WAS MOST LIKELY DUE TO PATIENT CONDITION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE MACHINE WAS CHECKED OUT BY A TERUMO BCT SERVICE TECHNICIAN AS PART OF THE INVESTIGATION. A SIMULATED USE TEST WAS PERFORMED USING A WHITE BLOOD CELL KIT. THE PROBLEM COULD NOT BE DUPLICATED DURING CHECKOUT. FUNCTIONALITY OF ALL ALARMS WAS VERIFIED, AND ALL NORMAL OPERATION OF THE SPECTRA MACHINE WAS VERIFIED. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT HAD COMPLICATIONS ON THE SPECTRA MACHINE DURING A PROCEDURE. TERUMO BCT IS ATTEMPTING TO OBTAIN FURTHER INFORMATION ABOUT THE INCIDENT,INCLUDING SPECIFICS ABOUT THE REPORTED PATIENT COMPLICATIONS AND IF ANY MEDICAL INTERVENTION WAS NECESSARY. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR INJURY OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TP PROVIDE THE PATIENT'S INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241348 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA APHERESIS SYSTEM GKT TERUMO BCT 000000000950000000

    Patients

    Seq Age Sex Outcome Treatment
    1