BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXTRACARPOREAL PHOTOPHERESIS KIT

    MDR report key: 562231 · Received December 15, 2004

    Report

    Report Number
    562231
    Event Type
    Other
    Date Received
    December 15, 2004
    Date of Event
    November 9, 2004
    Report Date
    December 15, 2004
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEAK WAS REPORTED AS A COMPLAINT TO COMPANY'S COMPANY IN 2004. THE LEAKING COMPONENT OF THE KIT, THE FLUID LOGIC MODULE COMMONLY CALLED THE CASSETTE, WAS RETURNED IN 2005. THE LEAK WAS CONFIRMED AS A LEAK AT ONE OF THE TUBING-TO-PORT BONDS OF THE CASSETTE. THIS CASSETTE WAS SUBSEQUENTLY RETURNED TO MEDICAL PRODUCTS WHO IS THE APPROVED CONTRACT MANUFACTURER OF THE KIT. THEIR INVESTIGATION CONFIRMED THE LEAK AND MICROSCOPIC PHOTOS ARE ATTACHED AS PART OF THEIR INVESTIGATION. THE KIT WAS RETURNED TO HARMAC AFTER SANITIZATION. VISUAL EXAMINATION OF THE AREA INDICATED AS LEAKING REVEALED NO CRACKS IN THE PORT AREA. HOWEVER, A PORTION OF THE BOND SOCKET AREA HAD A SLIGHTLY HAZY COLORING AND DID NOT APPEAR TO BE AS WELL BONDED AS OTHER PORTS. WATER LEAK TEST CONFIRMED THE PRESENCE OF A LEAK AT PORT 9. THE TUBE-TO-BOND SOCKET AREA OF THE FLM AT PORT 9 APPEARED TO AN ABNORMALLY HAZY APPEARANCE TO IT. REMAINING PIECE OF TUBING STILL IN BOND SITE COULD BE REMOVED FAIRLY EASILY INDICATING A POOR BOND. IT IS POSSIBLE TO NEGLECT TO DIP THE TUBING INTO THE SOLVENT DISPENSING DISH OR PERHAPS NOT TO DIP DEEP ENOUGH BEFORE INSERTING TUBE INTO FLM BOND SOCKET. ALL KITS RECEIVE A SYSTEM LEAK TEST IMMEDIATELY FOLLOWING THIS ASSEMBLY STEP. ROOT CAUSE HAS BEEN DETERMINED TO BE THAT THE TUBE-TO-SOCKET BOND RECEIVED A MINIMAL AMOUNT OF SOLVENT WHICH ALLOWED THE KIT TO PASS THE LEAK TEST BUT FAIL IN THE FIELD AS A RESULT OF THE AFFECTS OF STERILIZATION AND MANIPULATION OF KIT BY END USER. IN PRODUCTION THE DEPTH OF SOLVENT IN THE DISPENSING DISHES AS WELL AS THE ANGLE OF THE TUBING DIP, DIRECTLY IMPACT THE AMOUNT AND COVERAGE OF THE SOLVENT ON THE TUBE END. THE DIPPING STATIONS HAVE BEEN INSPECTED FOR PROPER OPERATION OF THE SOLVENT REFILL BOTTLES AND FOUND THEM ALL IN GOOD WORKING ORDER. OVERHEAD ACCESS TO THE SOLVENT POOL IS ALSO IMPORTANT IN THAT IT ALLOWS THE OPERATORS TO IMMERSE THE TUBE END AT A 90 DEGREE ANGLE RELATIVE TO THE SOLVENT. DIPPING THE TUBE AT A 45 DEGREE ANGLE, FOR EXAMPLE, WOULD RESULT IN INADEQUATE SOLVENT ON ONE SIDE OF TUBE AND POTENTIALLY TOO MUCH SOLVENT ON THE OTHER SIDE. ERGONOMICS OF THE FINAL ASSEMBLY WORKSTATIONS WAS CONFIRMED AS CORRECT. ALL ASSEMBLED KITS ARE INTEGRITY TESTED WITH AIR PRIOR TO PACKAGING AND STERILIZATION.

    Description of Event or Problem · 1

    PT HERE FOR ECP, EXTRACAPOREAL PHOTOPHORESIS TREATMENT, IN THE CANCER CENTER. PT WAS IN SECOND CYCLE OF PHOTOPHERESIS AND THE MACHINE ALARMED "SYSTEM OCCLUSION." NURSE EXAMINED MACHINE, KIT AND CONNECTIONS AND NOTICED BLOOD-TINGED FLUID LEAKING FROM THE BOTTOM OF THE FLUID LOGIC MODULE DOOR. IMMEDIATELY ABORTED TREATMENT, DISCONNECTED PATIENT FROM THE MACHINE AND NOTIFIED PHYSICIAN, BIOMED, RISK MANAGEMENT AND THERAKOS MFG, MANUFACTURER. VSS, VITAL SIGN STABLE, AFEBRILE, BLOOD CULTURES SENT ON ALL TRIPLE LUMEN NEOSTAR. FLUID LOGIC MODULE AND DATA KEY GIVEN TO BIOMED. PT WAS INSTRUCTED REGARDING S&S, SIGNS AND SYMPTOMS, OF INFECTION AND WAS TO CALL BMT AND GO TO THE ER IF FEBRILE OR ILL. POTENTIAL EXPOSURE TO CONTAMINATED BLOOD D/T, DUE TO, LEAKING STERILE ECP KIT. BLOOD CULTURES SENT ON TRIPLE LUMEN NEOSTAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACARPOREAL PHOTOPHERESIS KIT EXTRACARPOREAL PHOTOPHERESIS KIT LNR THERAKOS INC. CE0086/XT001 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR OTHER