BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA COLLECT ST

    MDR report key: 2623709 · Received June 12, 2012

    Report

    Report Number
    1722028-2012-00357
    Event Type
    Other
    Date Received
    June 12, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 16, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K103090
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. TWO DISPOSABLE SETS WERE RECEIVED. SET 1: USED/WET SET. THE TUBING WAS LOOSE FROM THE BROAD (LOOP) SIDE OF WHITE CELL CHAMBER. INSPECTION OF TUBE INDICATES THAT IT WAS LIKELY INSERTED 2/3 OF BOND LENGTH (I.E. THERE WAS A 1/3 SOCKET BOND GAP). POTENTIAL CAUSES: INADEQUATE INSERTION OF THE TUBE INTO THE BOND SOCKET, LACK OF SOLVENT, DELAY BETWEEN THE SOLVENT APPLICATION AND BONDING. SET 2: CLEAN/DRY SET: THE TUBING WAS LOOSE FROM BOTH SIDES OF THE WHITE CELL CHAMBER. INSPECTION OF THE TUBES INDICATES THAT THEY WERE LIKELY INSERTED 2/3 OF BOND LENGTH (I.E. THERE WAS A 1/3 SOCKET BOND GAP). POTENTIAL CAUSES: INADEQUATE INSERTION OF THE TUBE INTO THE BOND SOCKET , LACK OF SOLVENT, DELAY BETWEEN THE SOLVENT APPLICATION AND BONDING, AND/OR CUSTOMER TESTING THE SET BY PULLING ON THE TUBING. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    TERUMO BCT INTERNAL REFERENCE: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: THE DISPOSABLE SETS WERE RETURNED FOR INVESTIGATION AND NO GENERAL MIS-ASSEMBLIES WERE NOTED. THE ROOT CAUSE IS UNDETERMINED AT THIS TIME. POSSIBLE ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: BOND FAILURE OF COLLECT TUBING TO THE CHAMBER. WEAKENING OF THE BOND BY PULL-TESTING PRIOR TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING LEUKAPHERESIS (USING OPTIA SEPARATOR), THERE WAS DISJUNCTION OF TUBING AT THE JUNCTION BETWEEN THE OUTLET OF THE CELLS COLLECTION CHAMBER AND THE COLLECTING TUBING. THERE WAS A LEAK ALARM. THE PROCEDURE WAS INTERRUPTED WITHOUT HARM TO THE PT. CONSEQUENCES: PREMATURE TERMINATION OF COLLECTION OF STEM CELLS, A SECOND LEUKAPHERESIS WAS NEEDED TO COMPLETE THE COLLECTION. TERUMO BCT IS AWAITING THE RETURN OF THE DISPOSABLE SET. THIS REPORT IS BEING FILED DUE TO THE CUSTOMER FILLING A SAE REPORT WITH THEIR LOCAL COMPETENT AUTHORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA COLLECT ST SEPARATOR, AUTOMATED, BLOOD CELL AND P1 LKN TERUMO BCT 12T3127

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR