BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 8162094 · Received December 13, 2018

    Report

    Report Number
    2523595-2018-00173
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 14, 2018
    Report Date
    December 13, 2018
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION PTO LEAK. SINCE THIS REPORTABLE MALFUNCTION IS ONLY ASSOCIATED WITH THE KIT, THIS MDR WILL ONLY BE AGAINST THE KIT. A BATCH RECORD REVIEW FOR KIT LOT G350 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT G350 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, PTO LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER FOR EVALUATION. THE PHOTOGRAPH SHOWS EVIDENCE OF A BLOOD LEAK WITHIN THE PUMP TUBING ORGANIZER (PTO). THE EXACT LOCATION OF THE LEAK WITHIN THE PTO CANNOT BE IDENTIFIED IN THE CUSTOMER PHOTOGRAPH; HOWEVER, IT APPEARS THAT THE SOURCE OF THE LEAK COULD BE FROM THE PTO FILTER WELD OR THE TUBING BONDS INSIDE THE FILTER SOCKETS. THE PTO FILTER WELD AND TUBING BONDS INSIDE THE FILTER SOCKETS ARE 100% LEAK TESTED AS A SUBASSEMBLY AND AGAIN DURING FINISHED PRODUCT TESTING. A REVIEW OF THE MANUFACTURING HISTORY LOG FOUND NO UNSCHEDULED MAINTENANCE ASSOCIATED WITH THE PTO FILTER WELDER DURING THE MANUFACTURE OF KIT LOT G350. A DEVICE HISTORY RECORD REVIEW FOR KIT LOT G350 DID NOT IDENTIFY ANY RELATED NON-CONFORMANCES, AND THIS KIT LOT HAD PASSED ALL LOT RELEASE TESTING. THE ROOT CAUSE OF THE PTO LEAK COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. INVESTIGATION COMPLETE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT AN AIR DETECTED ALARM DURING BUFFY COAT COLLECTION. THE CUSTOMER STATED THAT AFTER THE ALARM A "POP" WAS HEARD AND IT BECAME APPARENT THAT THE TOP RIGHT CORNER OF THE PTO WAS LEAKING. THE LEAK OCCURRED AFTER APPROXIMATELY 1500 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE. THE CUSTOMER RETURNED A PHOTO FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998327 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS INC. NOT APPLICABLE G350 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1