BEUDAMED
    FDA Adverse Event Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 2970752 · Received February 20, 2013

    Report

    Report Number
    1722028-2013-00955
    Date Received
    February 20, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK020041
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: THE ROOT CAUSE IS INSUFFICIENT SOLVENT DURING THE MANUFACTURING PROCESS WHEN THE ASSEMBLER BONDED THE TUBING INTO THE SINGLE-PORT SIDE OF THE Y-CONNECTOR. THERE HAVE BEEN NO OTHER SIMILAR REPORTS FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RETURNED FOR EVALUATION. THE Y-CONNECTOR CLOSEST TO THE RETURN PUMP, BETWEEN THE RETURN PUMP AND THE RETURN PRESSURE SENSOR, WAS EVALUATED BECAUSE THE CUSTOMER INDICATED THIS AS THE LEAK LOCATION WITH A PEN MARK. LEAK TESTED THIS SECTION OF TUBING WITH AIR AND FOUND A LEAK PATH ON THE SINGLE PORT SIDE OF THE Y-CONNECTOR. 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 PATIENT INFORMATION.

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTION: MANUFACTURING STAFF WERE MADE AWARE OF THIS ISSUE AND RETRAINED TO THE APPROPRIATE PROCEDURES. AN INTERNAL CAPA WAS INITIATED TO CONDUCT A SYSTEMIC INVESTIGATION OF KNOWN SOLVENT RELATED FAILURES.

    Description of Event or Problem · 1

    PATIENT GENDER: FEMALE, PATIENT WEIGHT: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT THE Y CONNECTION BETWEEN THE PLASMA VALVE AND THE PLASMAPUMP DURING A MONONUCLEAR CELL (MNC). SHE STATED THEY WILL KEEP THE MNC PRODUCT THAT WAS COLLECTED SINCE THEY DO STERILITY TESTING ON IT. THE PRODUCT WAS COLLECTED FROM A DONOR. A CBC AND BLOOD CULTURES WERE DONE ON THE DONOR. THE CBC RESULTS WERE NORMAL AND THE BLOOD CULTURE RESULTS ARE PENDING. DONOR IS OK. THE PATIENT'S TREATMENT MAY BE DELAYED. 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
    74114 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL SET GKT TERUMO BCT 10U15286

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR