BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 3031351 · Received April 2, 2013

    Report

    Report Number
    1722028-2013-01068
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    K893962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A PRODUCT DISPOSITION FORM REVIEW WAS COMPLETED FOR THIS MACHINE SERIAL NUMBER AND NO MANUFACTURING-RELATED ISSUES WERE FOUND. 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. INVESTIGATION: NO FUNCTIONAL CHECKOUT OF THE DEVICE WAS PERFORMED AS NO MALFUNCTION OF THE DEVICE WAS ALLEGED. PER CONVERSATIONS WITH THE CUSTOMER, THIS INCIDENT IS ATTRIBUTED TO AN OPERATOR DATA ENTRY ERROR. ROOT CAUSE: OPERATOR ERROR AN INTERNAL ISSUE TRACKER HAS BEEN CREATED TO INVESTIGATE POSSIBLE MITIGATIONS FOR THE POSSIBILITY OF AN OPERATOR ENTERING A LOWER THAN PRESCRIBED HEMATOCRIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT APPROXIMATELY HALFWAY THROUGH A RED BLOOD CELL EXCHANGE PROCEDURE, THE OPERATOR REALIZED HE HAD ENTERED THE INCORRECT REPLACEMENT FLUID HEMATOCRIT(HCT). THE OPERATOR HAD ACCEPTED THE DEFAULT HCT OF 80%, BUT THEY WERE USING UNITS WITH A 55% HCT. THE TERUMO BCT SUPPORT SPECIALIST SUGGESTED TO THE CUSTOMER TO END THE PROCEDURE, GET THE PATIENT'S HCT, AND CONTACT THE PHYSICIAN. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION, IN THE FORM OF OPERATOR ERROR, THAT HAS THE POTENTIAL FOR INJURY.

    Description of Event or Problem · 1

    THE CUSTOMER COULD NOT PROVIDE THE PATIENT'S IDENTIFIER OR AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134138 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA APHERESIS SYSTEM GKT TERUMO BCT 000000000950000000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other