BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA THERAPEUTIC PLASMA EXCHANGE SET

    MDR report key: 1890840 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00046
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    July 18, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPERATOR DID NOT KNOW IF LAB SAMPLES HAD SHOWN HEMOLYSIS BEFORE THE TREATMENT. THE PATIENT WAS DOING FINE. THE OPERATOR DECIDED TO ABORT THE PROCEDURE AND CONTACT THE PHYSICIAN. THE PHYSICIAN INSTRUCTED THE OPERATOR TO SET UP A SECOND PROCEDURE FOR THE PATIENT. THIS SECOND PROCEDURE WAS SUCCESSFUL. ON THE DAY FOLLOWING THESE PROCEDURES, THE PHYSICIAN WAS READY TO RELEASE THE PATIENT TO OUTPATIENT CARE. NO MEDICAL INTERVENTION WAS PERFORMED. FOUR DAYS AFTER THE PROCEDURE, THE OPERATOR HAD NOT HEARD ANYTHING NEGATIVE ABOUT THE PT'S CONDITION. TTP MAY BE CHARACTERIZED BY HAEMOLYTIC ANEMIA IN THE PATIENT. ((B)(4), 2004). HOWEVER, IF HEMOLYSIS WAS ALREADY PRESENT IN THE PT, IT IS UNLIKELY THAT THE SECOND PROCEDURE WOULD HAVE BEEN DIFFERENT FROM THE FIRST PROCEDURE. EXTRA VASCULAR HEMOLYSIS CAN BE CAUSED BY RED BLOOD CELL EXPOSURE TO HIGH SHEER STRESSES. ((B)(4), 1996). TEMPERATURE MAY ALSO PLAY A ROLE. NOTHING FROM THE AVAILABLE EVIDENCE INDICATES THAT HIGH SHEER STRESSES OR INAPPROPRIATE TEMPERATURES WERE PRESENT DURING THE PROCEDURE. THE ROOT CAUSE OF THE MULTIPLE PLASMA LINE CONTAMINATION ALARMS WAS NOT DETERMINED CONCLUSIVELY. THIS ALARM MAY BE CAUSED BY MANY ISSUES WHICH INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING. THE ENTERED PT HEMATOCRIT IS LOWER THAN THE ACTUAL PATIENT HEMATOCRIT. THE FLUID BALANCE WITHIN THE PATIENT CHANGES SO THAT THE PATIENT'S ACTUAL HEMATOCRIT INCREASES. THE HEMATOCRIT OR OTHER PLASMA CONTAMINANTS IN THE PLASMA LINE EXCEEDED A PREDETERMINED AMOUNT. CLINICAL CONDITION OF THE PATIENT (FOR EXAMPLE: LIPEMIA) PRODUCES CONTAMINATION THAT ACTIVATES THE WARNING.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. THE OPERATOR RECEIVED SEVERAL PLASMA LINE CONTAMINATION ALARMS DURING A TPE PROCEDURE USING A COBE SPECTRA MACHINE AND DISPOSABLE. THE OPERATOR TERMINATED THE PROCEDURE BECAUSE OF THE POSSIBILITY OF HEMOLYSIS. THE DONOR WAS OBSERVED AND DID NOT EXPERIENCE ANY NEGATIVE HEALTH EFFECTS. THE PROCEDURE IN QUESTION WAS THE PATIENT'S 28TH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA THERAPEUTIC PLASMA EXCHANGE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 03S15024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other