BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 2860148 · Received November 21, 2012

    Report

    Report Number
    2523595-2012-00070
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PRODUCT RETURN. RETURNED KIT WAS RECEIVED BY THERAKOS ON (B)(6) 2012. CONCLUSION: UVAR XTS SYSTEM PROCEDURAL KIT WAS RECEIVED AND EVALUATED. NO MANUFACTURING DEFECT COULD BE FOUND IN THIS BOWL THAT WOULD HAVE CAUSED THE SEAL LEAK. NO ROOT CAUSE FOR THE ISSUE COULD BE DEFINITIVELY DETERMINED. A POTENTIAL ROOT CAUSE FOR THE BLOOD LEAK ALARM IS BACK PRESSURE IN THE SYSTEM CAUSED BY OCCLUSIONS OR BLOOD CLOTS THAT LIFTED THE BOWL SEAL AND ALLOWED SOME BLOOD TO LEAK OUT INTO THE CENTRIFUGE CHAMBER. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. SHOULD A TREND ARISE, FURTHER ACTION WILL BE TAKEN. THERAKOS MEDICAL AFFAIRS RATED THIS EVENT AS A REPORT OF A NON SERIOUS INJURY. MEDICAL AFFAIR ASSESSMENT: THIS IS AN ORDINARY LEAK NOT DIFFERENT FROM ANY OTHER AND NO PROPHYLAXIS NEEDED. (B)(4). THE CUSTOMER DID NOT REPORT ANY MEDICATIONS THAT THE PATIENT WAS TAKING AT THE TIME OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CENTRIFUGE BLOOD LEAK ALARM THAT OCCURRED DURING A TREATMENT PROCEDURE. ISSUE STARTED ON: (B)(6) 2012. ISSUE NOTICED: IN CYCLE 6 OF TREATMENT. TREATMENT RESTARTED: NO. ASSOCIATED PROCEDURAL KIT: KIT TYPE: XT125. KIT LOT NUMBER: A730. CUSTOMER STATED A BLOOD LEAK ALARM OCCURRED DURING CYCLE 6, AND SHE FOUND WHAT APPEARED TO BE PLASMA HAD LEAKED AROUND THE TOP OF THE CENTRIFUGE. TREATMENT WAS ENDED. CUSTOMER STATED THERE WAS AN UNUSUAL NOISE FROM THE BOWL OR CENTRIFUGE SHORTLY BEFORE THE LEAK ALARM OCCURRED. CUSTOMER STATED ANOTHER KIT FROM THE SAME LOT ALSO HAD MADE AN UNUSUAL NOISE DURING CYCLE 6 OF A TREATMENT YESTERDAY, AND THAT AFTER THE NOISE SHE IMMEDIATELY ENDED CYCLE 6 AND SUCCESSFULLY COMPLETED YESTERDAY'S TREATMENT, WITH NO LEAK ALARMS YESTERDAY. CUSTOMER CONSULTED ATTENDING PHYSICIAN ON WHETHER ANY VOLUME FROM THIS KIT SHOULD BE RETURNED TO THE PATIENT, THEN MANUALLY RETURNED THE VOLUME EXCEPT FOR THE VOLUME IN THE BOWL. CUSTOMER ESTIMATED ABOUT 100ML BLOOD WAS NOT RETURNED TO THE PATIENT. CUSTOMER STATED THE PATIENT WAS BEING ADMINISTERED A PROPHYLACTIC ANTIBIOTIC IV AT THE TIME THE EVENT WAS REPORTED TO THERAKOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS XTS PHOTOPHERESIS SYSTEM UVAR XTS PHOTOPHERESIS SYSTEM LNR THERAKOS 6660 A730

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR