BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 9576193 · Received January 10, 2020

    Report

    Report Number
    2523595-2020-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 12, 2019
    Report Date
    February 26, 2020
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE COMPLAINT KIT WITH SMART CARD FOR INVESTIGATION. A REVIEW OF THE SMART CARD DATA VERIFIED THE OCCURRENCE OF ALARM #53: RETURN LINE AIR DETECTED WARNINGS. A VISUAL INSPECTION OF THE RETURNED KIT DID NOT FIND ANY CRACKS OR DAMAGE TO THE PUMP TUBING ORGANIZER (PTO) OR THE PTO FILTER; HOWEVER, DRIED BLOOD WAS FOUND ON AND INSIDE THE PTO. THE KIT WAS PRESSURE TESTED TO CHECK FOR LEAKS AND A LEAK WAS CONFIRMED AT THE WELDED JOINT BETWEEN THE FILTER COVER AND THE BASE OF THE PTO. A MATERIAL TRACE OF THE RELATED COMPONENTS USED TO BUILD LOT H132 DID NOT FIND ANY NON-CONFORMANCES. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT RESULT IN ANY RELATED NON-CONFORMANCES. THIS LOT PASSED ALL LOT RELEASE TESTING. THE CAUSE FOR ALARM #53: RETURN LINE AIR DETECTED WAS DUE TO THE PTO LEAK. THE ROOT CAUSE OF THE PTO LEAK WAS MOST LIKELY A WEAK WELD AT THE FILTER IN THE PTO. THE CAUSE FOR THE WEAK WELD COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. MC: (B)(6). (B)(4).

    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 H132 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT H132 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, PTO LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. AT THE TIME OF THIS REPORT, THE ANALYSIS OF THE KIT AND SMARTCARD IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THAT THEY EXPERIENCED A PTO LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER STATED THAT AFTER PHOTOACTIVATION THE INSTRUMENT WAS RETURNING THE 50 ML OF BLOOD FROM THE RETURN BAG AT THE TIME THE LEAK OCCURRED. THE TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION; HOWEVER, THE PATIENT'S PHYSICIAN REQUESTED A SALINE BAG TRANSFUSION BE GIVEN TO THE PATIENT. THE CUSTOMER RETURNED THE KIT WITH SMART CARD FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41732 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS INC. H132

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR