BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS SYSTEM

    MDR report key: 3964292 · Received June 19, 2014

    Report

    Report Number
    2523595-2014-00167
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C710 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES RELATED TO THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED; HOWEVER, MANUFACTURER'S CAPA (B)(4) IS ALREADY IN PROGRESS TO INVESTIGATE CENTRIFUGE BOWEL LEAK/BREAK. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT MULTIPLE ALARMS. CUSTOMER STATED SHE WAS IN THE 4TH DRAW CYCLE AND WAS HAVING PROBLEMS WITH ACCESS CONSISTENTLY THROUGHOUT THE PROCEDURE. CUSTOMER FLUSHED THE HICKMAN ACCESS FREQUENTLY, BUT WAS ONLY ABLE TO COLLECT AT 7-8ML/MIN. CUSTOMER INSERTED A 24GA IV IN HOPES OF RETURNING THE PATIENT'S BLOOD. DURING THE 4TH CYCLE, CUSTOMER COULD NOT CLEAR PATIENT OCCLUSION ALARMS. CUSTOMER FLUSHED THE ACCESS, BUT COULD NOT GET BLOOD RETURN. CUSTOMER STATED SHE RECEIVED AIR DETECTED ALARMS, AND DID A SALINE BOLUS. CSS ASKED THE CUSTOMER IF SHE SAW AIR IN THE LINES, AND CUSTOMER DID NOT PROVIDE AN ANSWER AS SHE WAS FOCUSED ON OTHER DETAILS ABOUT THE PROCEDURE. CUSTOMER STATED SHE RECEIVED A BLOOD LEAK DETECTED ALARM AND WAS UNABLE TO BYPASS THE ALARMS SO SHE CALLED CSS. CSS ADVISED THE CUSTOMER TO REMOVE THE CENTRIFUGE BOWEL AND EXPLAINED THE PROCEDURE. CSS ASKED THE CUSTOMER TO TAKE GAUZE AND WIPE THE BOWEL TO CHECK FOR MOISTURE. CUSTOMER STATED SHE NOTICED A PINK-TINGED MOISTURE AT THE BOTTOM OF THE BOWEL. CSS ADVISED THE CUSTOMER TO ABORT THE TREATMENT DUE TO POSSIBLE AIR CONTAMINATION. CUSTOMER ABORTED THE TREATMENT. PATIENT'S CONDITION WAS STABLE. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360971 THERAKOS XTS SYSTEM LNR THERAKOS, INC. C710-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR