BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER MINI KIT

    MDR report key: 3912103 · Received July 3, 2014

    Report

    Report Number
    1625685-2014-00125
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K121849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS: ONE (1) SAMPLE WAS SUBMITTED FOR EVALUATION. THE VALVE SAMPLE WAS PROVIDED BY THE CUSTOMER WITH A SHORT PIECE OF THE CATHETER TUBING. THE FOLLOWING STEPS WERE TAKEN TO ANALYZE THE SAMPLE: THE VALVE WAS DISASSEMBLED. BOTH THE DISC AND DUCKBILL VALVE HAD SOME DRIED ORGANIC MATTER WHICH WAS FLAKY AND SLIGHTLY YELLOW IN COLOR. THE DISC APPEARED SLIGHTLY CONCAVE WHERE THE CENTER PORTION WAS PUSHED DOWN SLIGHTLY INTO THE VALVE, LIKELY FROM REPEATED ACCESS. THE DUCKBILL VALVE SHOWED ABNORMAL DAMAGE. THE SHAPE WAS DEFORMED COMPARED WITH AN UNUSED VALVE. ADDITIONALLY IT HAD A LARGE HOLE THROUGH IT. THE MATERIAL FELT SQUISHY AND LESS ELASTIC THAN AN UNUSED VALVE. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. LIKEWISE, A REVIEW OF ALL MANUFACTURING METHODS AND PERSONNEL INVOLVED IN THE ASSEMBLY OF THE DEVICE DETERMINED THERE WAS NO CONTRIBUTION FROM EITHER TO THE REPORTED ISSUE. EVERY CATHETER ASSEMBLY IS SUBJECTED TO EXTENSIVE FUNCTIONAL TESTING AND INSPECTION DURING THE ASSEMBLY PROCESS TO VERIFY PERFORMANCE AND CONFORMITY TO ENGINEERING DESIGN. A REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INVOLVED COULD NOT BE COMPLETED AS LOT NUMBER INFORMATION WAS NOT AVAILABLE. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. THE ANALYSIS CONFIRMED THAT THE DUCKBILL VALVE MATERIAL WAS DAMAGED AND A HOLE HAD FORMED THROUGH THE VALVE LIKELY RESULTING FROM REPEATED ACCESS OF THE VALVE MATERIAL. HOWEVER, IT IS UNKNOWN WHY THE DUCKBILL VALVE¿S MATERIAL WAS DAMAGED. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THE MANUFACTURING PLANT IS CONTINUING TO MONITOR THIS ISSUE TO IDENTIFY THE NEED FOR ACTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER (B)(6) REPORTED THE PATIENT HAD A PLEURX PLEURAL CATHETER PLACED IN (B)(6) 2013.  LONG TERM ACCESS HAS APPEARED TO HAVE CAUSED THE VALVE TO LEAK AND IT HAD TO BE REPLACED. THE DEVICE WAS USED ON A PATIENT. THE PATIENT WAS NOT INJURED BY THE DEVICE. THE PATIENT IS FINE AND CATHETER IS FUNCTIONING WELL WITH A NEW VALVE IN PLACE. THE CUSTOMER INDICATED THAT PER THE PATIENT'S PHYSICIAN, THE VALVE IS AN "OLD" VALVE (WITHOUT THE "PLEURX" LOGO). THE FEMALE PATIENT HAS LUNG CANCER (MALIGNANT PLEURAL EFFUSION). THE HOME CARE NURSES NOTED THAT AFTER DRAINAGE, THE VALVE WOULD LEAK FLUID AFTER THE BOTTLE WAS DISCONNECTED.  THE PATIENT DENIED THAT ANY OTHER INSTRUMENT WAS INSERTED THROUGH THE VALVE BESIDES THE BOTTLES.  ALTHOUGH THE FLUID LEAKED OUT, THERE DID NOT APPEAR TO BE ANY AIR LEAK AS THERE WAS NO SIGN OF PNEUMOTHORAX ON X-RAY. THE HOME CARE NURSES BEGAN CLAMPING THE CATHETER WITH THE BLUE CLAMP AFTER THEY NOTICED IT LEAKING. THE PATIENT HAD THE CATHETER IN FOR OVER A YEAR AND WAS BEING FOLLOWED-UP WITH, WITH NO CONCERNS PRIOR TO THE LEAK BEING NOTED. THE PATIENT IS NOT PART OF ANY DRUG TRIAL. ON (B)(6) 2014, THE ANEXXA SALES REPRESENTATIVE (B)(6) PROVIDED THE FOLLOWING INFORMATION: THERE WAS NO DIFFICULTY NOTED DURING PLACEMENT OF THE CATHETER AND EVERYTHING WORKED FINE FOR ALMOST A YEAR. THE LOT NUMBER IS UNKNOWN. THE PATIENT DID NOT RECEIVE RADIATION AS PART OF HER THERAPY BUT WAS GIVEN GEFITINIB, THEN 4 CYCLES OF CISPLATIN/GEMCITABINE. THE CATHETER WAS NOT USED TO INFUSE ANYTHING AND THE ONLY CLEANING SOLUTIONS USED WERE FROM THE BOTTLE DRAINAGE KITS. THE DRAINAGES WERE PERFORMED BY HOME CARE NURSES AND THERE WAS NO REPORT OF ANY DIFFICULTY WITH THE DRAINAGES. THE LEAK WAS NOTED ON (B)(6) 2014 AND ONLY THE VALVE WAS REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390242 PLEURX PLEURAL CATHETER MINI KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 50-7050

    Patients

    Seq Age Sex Outcome Treatment
    1 GEFITINIB| CISPLATIN/GEMCITABINE