BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS UVAR XTS

    MDR report key: 3669733 · Received December 13, 2013

    Report

    Report Number
    2523595-2013-00192
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    November 26, 2013
    Report Date
    November 26, 2013
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT B712 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. LOT MET RELEASE REQUIREMENTS. COMPLAINT LOT REVIEW CONDUCTED AND NO ADDITIONAL COMPLAINTS FOR CENTRIFUGE BOWL LEAK WERE REPORTED TO DATE FOR THIS LOT. NO TRENDS DETECTED. SERVICE ORDER (B)(4): SERVICE ENGINEER PERFORMED SYSTEM CHECK OUT PROCEDURE; CHECKED OUT OK. SYSTEM RUNS WITHIN SPECIFICATIONS. INSTRUMENT IS OPERATING AS EXPECTED. ALL PAPERWORK WAS LEFT WITH THE CUSTOMER. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT RETURN WAS RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE ROOT CAUSE FOR THIS COMPLAINT CANNOT BE DETERMINE BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK THAT OCCURRED DURING A TREATMENT PROCEDURE. NAE AND FUNCTION OF COMPLAINANT: SAME AS REPORTER. CUSTOMER CALLED TO REPORT A BLOOD LEAK. BLOOD WAS FOUND IN THE BAG ON THE LEFT SIDE OF THE INSTRUMENT. TREATMENT WAS ABORTED. PATIENT IS FINE. BLOOD LOSS FOR THE PATIENT WAS AROUND 100ML. NO TRANSFUSION NEEDED AND NO MEDICATION GIVEN DUE TO THE EVENT. PATIENT RELEASED TO GO HOME. SERVICE ORDER (B)(4) WAS DISPATCHED TO SERVICE SERIAL NUMBER (B)(4). CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652546 THERAKOS UVAR XTS XTS LNR THERAKOS INC. 6662 B712 KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR