BEUDAMED
    FDA Adverse Event Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 3023559 · Received March 27, 2013

    Report

    Report Number
    1722028-2013-01064
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 5, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK020041
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    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. BIOBURDEN TESTING WAS PERFORMED ON THIS LOT PRIOR TO RELEASE. THE BIOBURDEN RESULTS FOR THIS LOT WERE WITHIN NORMAL LEVELS. GRAM-POSITIVE COCCI CAN BE ORGANISMS THAT ARE UBIQUITOUS IN THE ENVIRONMENT AND MAY BE ISOLATED FROM HUMANS AND ANIMALS. GRAM-POSITIVE COCCI ARE COMMONLY FOUND AS PART OF NORMAL FLORA ON HUMAN SKIN. TERUMO BCT SPECTRA PRODUCTS ARE STERILIZED USING AN ETHYLENE OXIDE (ETO) STERILIZATION PROCESS. THIS CORRELATES TO A STERILITY ASSURANCE LEVEL (SAL) OF < 10-6 WHICH MEANS THE PROBABILITY OF ASPECTRA SET HAVING A BACTERIA ORGANISM SURVIVE THE STERILIZATION PROCESS IS LESS THAN 1 IN 1 MILLION A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. BASED ON THE RESULTS OF OUR BIOBURDEN TESTING AND OUR ETO PROCESS, IT IS UNLIKELY THAT THIS FORM OF BACTERIA IS ASSOCIATED WITH THE DISPOSABLE SET. ALTHOUGH NOT CONCLUSIVE, IT IS MOST LIKELY THAT THIS FORM OF BACTERIA WAS THE RESULT OF THE DONOR VENIPUNCTURE PROCEDURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED POSITIVE BLOOD CULTURES ON AN AUTOLOGOUS STEM CELL PRODUCT. AEROBIC AND ANAEROBIC BLOOD CULTURES OF THE PRODUCT GREW GRAM + COCCI IN CLUSTERS. THE PATIENT RECEIVED ANTIBIOTICS AFTER THE COLLECTION. THE PATIENT HAD NEGATIVE BLOOD CULTURES AND IS STABLE. THEY DECIDED NOT TO USE THE THIS PRODUCT AND THE PATIENT WILL UNDERGO ANOTHER COLLECTION. THE CUSTOMER WAS UNABLE TO PROVIDE THE PATIENT'S AGE. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126618 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL SET GKT TERUMO BCT 10U15214

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR