BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 16477534 · Received March 3, 2023

    Report

    Report Number
    3013428851-2023-00008
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 2, 2023
    Report Date
    June 6, 2023
    Manufacturer
    MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT KIT AND PHOTOGRAPHS WERE RETURNED FOR EVALUATION. REVIEW OF THE CUSTOMER PROVIDED PHOTOGRAPHS VERIFY THE REPORTED TUBING LEAK AS THE RECIRCULATION PUMP TUBING IS SEEN DETACHED FROM THE TUBING PORT. THE PHOTOGRAPHS VERIFY THE CUSTOMER REPORT OF PLASMA LEAKING ON THE PUMP DECK. EXAMINATION OF THE RECEIVED KIT VERIFIED THE RECIRCULATION PUMP TUBING WAS NO LONGER BONDED TO THE T-CONNECTOR PORT. FURTHER INSPECTION OF THE KIT FOUND A LACK OF SOLVENT ON THE TUBING THAT IS BONDED TO THE T-CONNECTOR PORT. THE TUBING DETACHING FROM THE BOND PORT INDICATES THE SOLVENT BOND JOINT WAS INSUFFICIENT. A MATERIAL TRACE OF THE TUBING AND ITS COMPONENTS USED TO BUILD LOT L112 FOUND ONE RELATED NON-CONFORMANCE. THE RELATED NON-CONFORMANCE WAS ASSOCIATED WITH BLACK STRIPE TUBING LOT # 1010393 WHICH INVOLVED A LEAK IDENTIFIED AT THE SAME LOCATION DURING LOT RELEASE TESTING FOR A DIFFERENT KIT LOT. A DEVICE HISTORY RECORD REVIEW FOR KIT LOT L112 DID NOT IDENTIFY ANY RELATED NON-CONFORMANCES AND THIS KIT LOT HAD PASSED ALL LOT RELEASE TESTING. THE ROOT CAUSE OF THE TUBING LEAK IS MOST LIKELY DUE TO MANUFACTURING OPERATOR ERROR DURING THE TUBE BONDING OPERATION. RETRAINING WAS COMPLETED WITH ALL BONDING OPERATORS AT THE MANUFACTURING FACILITY. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. (B)(6) 2023.

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION TUBING 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 L112 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT L112 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, TUBING 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 RETURNED PHOTOGRAPHS AND KIT ARE STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4). (B)(6) 2023.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A TUBING LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE LEAK WAS OBSERVED DURING THE BUFFY COAT COLLECTION PHASE OF THE PROCEDURE. THE LEAK APPEARED TO BE COMING FROM THE LOCATION OF THE RECIRCULATION PUMP TUBING. THE CUSTOMER ABORTED THE ECP TREATMENT AND MANUALLY RETURNED THE BLOOD FROM THE RETURN BAG TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION AND BEGAN A NEW ECP TREATMENT WITH A NEW KIT. THE CUSTOMER WILL RETURN THE COMPLAINT KIT AND PHOTOGRAPHS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858063 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED NA L112

    Patients

    Seq Age Sex Outcome Treatment
    1 Male