BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 6191641 · Received December 20, 2016

    Report

    Report Number
    1722028-2016-00659
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 20, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K153601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED RELATED TO THE HYPERVOLEMIA. PER THE RDF ANALYSIS, IT IS POSSIBLE THAT THE SALINE CLAMP REMAINED OPEN FOR A DURATION DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COLLECTION SET WAS ANALYZED. VISUAL EXAMINATION CONFIRMED THAT THE INLET AND RETURN SALINE LINE ROLLER CLAMPS WERE PRESENT AND LOCATED CORRECTLY. UPON RECEIPT IT WAS OBSERVED THAT THE RETURN SALINE CLAMP WAS CLOSED, WHERE AS THE INLET SALINE LINE CLAMP WAS OPEN. FURTHER EXAMINATION OBSERVED THE PRESENCE OF RBC¿S IN THE RETURN SALINE LINE. THE CLAMP WAS VISUALLY INSPECTED AND NO OBVIOUS MANUFACTURING DEFECTS WERE FOUND. VISUAL EXAMINATION OF THE SET CONFIRMED THE PRESENCE OF PLATELET AGGREGATES WITHIN THE CHANNEL AND CHAMBER. FURTHER PLATELET AGGREGATION WAS OBSERVED IN THE RETURN PUMP HEADER TUBING. THE SET WAS FURTHER EXAMINED FOR ANY KINKS, LEAKS, OCCLUSIONS, MISSING PARTS OR OTHER MISASSEMBLY AND NONE WERE FOUND. THE RUN DATA FILE (RDF) WAS ANALYZED. PER THE CUSTOMER, THE SALINE BAG WAS EMPTY DESPITE BOTH SALINE LINE ROLLER CLAMPS BEING CLOSED. ALTHOUGH THE STATUS OF THE ROLLER CLAMPS CANNOT BE DEFINITELY CONFIRMED FROM THE RDF, THE RDF INDICATES THAT THE PROCEDURE HAD BEEN PAUSED IN RESPONSE TO INLET PRESSURE ALARMS DURING THE PROCEDURE. IF THE CUSTOMER HAD OPENED THE INLET SALINE LINE ROLLER CLAMP TO HELP FLUSH THE INLET LINE OF ANY OBSTRUCTIONS AND IT WERE NOT CLOSED WHEN THE PROCEDURE WAS RESUMED, AN OPEN INLET SALINE ROLLER CLAMP WOULD EXPLAIN WHY THE SALINE BAG WAS EMPTY WHEN THE PROCEDURE WAS ULTIMATELY ENDED. THEREFORE, THE POSSIBILITY OF THE INLET SALINE LINE ROLLER CLAMP BEING LEFT OPEN AFTER THE SYSTEM WAS PAUSED CANNOT BE RULED OUT. AT THE END OF THE RUN, THE SYSTEM REPORTED THE FLUID BALANCE OF THE PATIENT TO BE 109% (I.E. 332 ML POSITIVE). THE CUSTOMER INDICATED 500 ML OF SALINE WERE IN ADVERTENTLY DELIVERED TO THE PATIENT MAKING THE ACTUAL PREDICTED FLUID BALANCE OF THE PATIENT 832 ML POSITIVE. THE PATIENT¿S TBV IS 3699 ML. THEREFORE, THE ESTIMATED ENDING FLUID BALANCE OF THIS PATIENT GIVEN THE DESCRIBED PROCEDURE EVENTS IS 122%.

    Description of Event or Problem · 1

    DUE TO (B)(6) PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. PATIENT'S GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FOLLOWING A MONONUCLEAR CELL (MNC) COLLECTION PROCEDURE, THEY SUSPECTED THEIR PATIENT WAS +332 ML AT THE END OF THE PROCEDURE. IN ADDITION, THEY REPORTED THAT 500 ML OF SALINE WERE INADVERTENTLY DELIVERED TO THE PATIENT MAKING THE ENDING FLUID BALANCE OF THE PATIENT 832 ML OR 122%.PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE AT THIS TIME. THE PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841333 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 07Z3101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other