BEUDAMED
    FDA Adverse Event Summary report: N

    COBE SPECTRA

    MDR report key: 2870466 · Received December 12, 2012

    Report

    Report Number
    1722028-2012-00910
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 20, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK020041
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: A SECOND ROUND OF CULTURING WAS PERFORMED BY THE CUSTOMER. THE SAME PRODUCT WITH NEGATIVE FINAL RESULTS FROM THE FIRST ROUND OF TESTING WAS ALSO NEGATIVE FOR THE SECOND ROUND OF TESTING. THE OTHER TWO PRODUCTS WERE FOUND TO BE POSITIVE FOR STAPH EPIDERMIS IN THE SECOND ROUND OF TESTING. AN UNUSED SET FROM THE SAME LOT WAS RETURNED BY THE CUSTOMER AND INSPECTED. NO MANUFACTURING DEFECTS WERE FOUND AND ALL END CAPS WERE IN PLACE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE POSITIVE BACTERIAL CULTURE RESULTS COULD NOT BE DETERMINED. BASED ON THE TYPE OF BACTERIA, IT IS POSSIBLE THAT THE BACTERIA MAY HAVE BEEN INTRODUCED WHEN THE CATHETER WAS PLACED, WHEN THE SAMPLES WERE TAKEN, OR DURING THE PROCESSING OF THE SAMPLES. STAPHYLOCOCCUS SPECIES ARE COMMONLY FOUND AS NORMAL FLORA OF THE HUMAN SKIN. CONSEQUENTLY BECAUSE STAPHYLOCOCCUS EPIDERMIDIS MAKES UP PART OF THE NORMAL FLORA OF HUMAN SKIN, THIS ORGANISM MAY BE ASSOCIATED WITH CONTAMINATED BLOOD PRODUCTS BECAUSE THE COLLECTION OF BLOOD PRODUCTS DOES NOT OCCUR IN A STERILE ENVIRONMENT. TERUMO BCT SPECTRA PRODUCTS ARE STERILIZED USING AN ETHYLENE OXIDE (ETO) STERILIZATION PROCESS. (B)(4). STAPHYLOCOCCUS ORGANISMS ARE VEGETATIVE CELLS WITH NO KNOWN INNATE RESISTANCE TO ETHYLENE OXIDE STERILIZATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: ALL THREE COLLECTIONS WERE PERFORMED BY THE SAME OPERATOR, WHO STATES SHE FOLLOWED ASEPTIC TECHNIQUE IN LOADING, PRIMING, CONNECTING AND DISCONNECTING THE PATIENT AND IN DISCONNECTING THE COLLECTED PRODUCTS. THE PRODUCTS WERE THEN TAKEN TO THE LAB WHERE THEY UNDERWENT ADDITIONAL PROCESSING UNDER A LAMINAR FLOW HOOD AND WERE THEN FROZEN PENDING FINAL CULTURE RESULTS. PRELIMINARY CULTURE RESULTS REVEALED POSITIVE CULTURES ON ALL THREE PRODUCTS AT WITHIN 24 HOURS-POST EACH COLLECTION. THE IDENTIFIED BACTERIA WAS STAPH EPI, BUT EACH OF THE THREE WAS A DIFFERENT BIOTYPE. BLOOD CULTURES AND CULTURES OF THE CATHETER SITE WERE NOT DONE ON THIS PATIENT. THE PATIENT DID HAVE AN MRI OF THE HEAD DURING THE WEEK OF THE MNC COLLECTIONS DUE TO HEADACHES AND WAS FOUND TO HAVE INFLAMMATION OF SINUSITIS AND WAS TREATED WITH ANTIHISTAMINES BUT WAS NOT GIVEN ANY ANTIBIOTICS, BUT THIS WAS NOT DONE IN RELATION TO THE POSITIVE PRODUCT CULTURES. FINAL BACTERIAL CULTURE RESULTS CAME BACK. THE CUSTOMER STATED THAT ONE WAS NEGATIVE AND TWO WERE POSITIVE. IT IS NOT YET CLEAR WHICH RESULTS BELONG TO WHICH SAMPLES. THEY ARE RECULTURING THE TWO THAT WERE POSITIVE. FOLLOW-UP WILL BE PERFORMED TO DETERMINE FINAL RESULTS. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THREE CONSECUTIVE AUTOLOGOUS STEM CELL COLLECTIONS FROM THE SAME PATIENT ALL HAD POSITIVE PRELIMINARY BLOOD CULTURE RESULTS. THE PATIENT HAD AN INTERNAL JUGULAR CENTRAL VENOUS CATHETER PLACED ON (B)(6)2012 AND UNDERWENT THREE MONONUCLEAR CELL (MNC) COLLECTION PROCEDURES USING DISPOSABLE SETS OF THE SAME LOT NUMBER ON (B)(6) 2012. FOLLOWING THE THIRD COLLECTION, THE CENTRAL VENOUS CATHETER WAS REMOVED AND DISCARDED. THEY DID NOT CULTURE THE CATHETER OR THE PATIENT. ALL THREE DISPOSABLE SETS WERE DISCARDED FOLLOWING EACH OF THE COLLECTION PROCEDURES, SO THEY ARE NOT AVAILABLE FOR RETURN. THE CUSTOMER STATED THAT THE PATIENT IS OTHERWISE WELL AND ASYMPTOMATIC FOR ANY OTHER TYPES OF INFLAMMATION OR INFECTIONS. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WEIGHT IS NOT AVAILABLE PER THE CUSTOMER. THE CUSTOMER WOULD NOT PROVIDE THE PATIENT ID DUE TO HIPPA REGULATIONS. THE CUSTOMER DID PROVIDE THE UNIT IDENTIFICATION NUMBERS FOR EACH OF THE THREE MNC PRODUCTS THAT WERE COLLECTED AND POSITIVE FOR BACTERIA: (B)(6) 2012 - (B)(6). THE DISPOSABLE SETS ARE NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED THEM. THE CUSTOMER STATED THAT THESE WERE THE FIRST THREE DISPOSABLE SETS IN THIS LOT NUMBER THAT THEY HAVE USED IN THEIR FACILITY. SHE IS RETURNING ONE OF THE UNUSED SETS FROM THIS CASE FOR INVESTIGATION. 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
    1 COBE SPECTRA COBE SPECTRA WBC SET GKT TERUMO BCT 07U15266

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR ANTIHISTAMINES FOR INFLAMMATION SINUSITIS