BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 3973506 · Received August 1, 2014

    Report

    Report Number
    1625685-2014-00128
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 6, 2014
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K121849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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):ONE (1) SAMPLE WAS SUBMITTED FOR EVALUATION. A FULL VISUAL AND FUNCTIONAL INSPECTION WAS COMPLETED. A REVIEW OF ALL METHODS AND PERSONNEL USED IN THE ASSEMBLY OF THE DEVICE DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. CONSEQUENTLY, THE INVESTIGATION DETERMINED NO CONTRIBUTION OF MANUFACTURING PERSONNEL TO THE REPORTED COMPLAINT FAILURE MODE EXISTS. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY INSPECTION PLANS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE IDENTIFIED DEFECT. EVERY CATHETER ASSEMBLY IS SUBJECTED TO EXTENSIVE FUNCTIONAL TESTING AND INSPECTION DURING THE ASSEMBLY PROCESS TO VERIFY PERFORMANCE AND CONFORMITY TO ENGINEERING DESIGN. CONSEQUENTLY, THE INVESTIGATION DETERMINED NO CONTRIBUTION OF THE MANUFACTURING PROCESSES TO THE REPORTED COMPLAINT FAILURE MODE EXISTS. A REVIEW OF ALL MATERIALS USED IN THE ASSEMBLY OF THE CATHETER DEVICE COULD NOT BE PERFORMED WITHOUT A LOT NUMBER BEING PROVIDED. MOST PROBABLE CAUSE COULD NOT DETERMINED SINCE THE ANALYSIS COULD NOT REPLICATE THE REPORTED FAILURE MODE OF LEAKING DURING DRAINING. ADDITIONALLY THE VALVE DID NOT LEAK WHEN PRESSURIZED WITH AIR. LASTLY THE COMPONENTS DID NOT HAVE ANY NOTED DEFECTS AND THE MATERIAL CONDITION APPEARED NORMAL. THE ANALYSIS WAS INCONCLUSIVE IN DETERMINING ROOT CAUSE OF THE FAILURE DESCRIBED IN THE COMPLAINT.

    Description of Event or Problem · 1

    VIA EMAIL, IT WAS REPORTED THAT THE PATIENT HAD THE CATHETER FOR APPROX. 6 TO 8 WEEKS. OVER TIME, AIR BUBBLES INCREASED AND FLUID DECREASED; PHYSICIANS CHECKED THE CATHETER TO FIND THIS ONE PULLS IN AIR FROM THE VALVE WHEN THE BOTTLE CATHETER TIP IS INSERTED INTO THE VALVE. THE VALVE WAS REPAIRED. THERE WAS NO INJURY INVOLVED. THE SAMPLE IS AVAILABLE FOR EVALUATION. ON (B)(6) 2014, VIA TELEPHONE, THE ACCOUNT'S SALES REPRESENTATIVE (S. ROBERTSON) PROVIDED THE FOLLOWING INFORMATION ON BEHALF OF THE CUSTOMER: THE LOT NUMBER IS UNKNOWN. THE PATIENT HAS MALIGNANT PLEURAL EFFUSION. THE PATIENT WAS NOT RECEIVING ANY RADIATION OR CHEMOTHERAPY TREATMENT. NO OTHER TYPES OF PROCEDURES WERE PERFORMED WITH THE CATHETER, ONLY THE INTENDED EFFUSION DRAINAGES. THE CATHETER IS IN THE PLEURAL SPACE. THERE WAS NO DIFFICULTY NOTED DURING INITIAL PLACEMENT OF THE CATHETER. THE PATIENT ONLY USED CAREFUSION ISSUED SUPPLIES TO CLEAN THE VALVE. AT ABOUT THE 6TH-8TH WEEK OF THE CATHETER BEING IN PLACE, THE PATIENT STARTED TO NOTE FLUID DIMINISHED WHEN PERFORMING DRAINAGES BUT STILL FELT FULL AND STARTED TO SEE MORE AND MORE AIR BUBBLES. THE PATIENT WOULD HEAR A HISSING SOUND COMING FROM THE VALVE BUT ONLY WHEN HE WOULD PLACE AN ACCESS DILATOR IN SO IT IS AS IF THE VALVE WAS NOT SEALING TIGHTLY AROUND THE ACCESS DILATOR TIP. ON (B)(6) 2014, ONLY THE VALVE WAS REPLACED BY SPLICING OFF A NEW VALVE FROM A NEW PLEURX TRAY WITH APPROXIMATELY TWO INCHES OF THE NEW CATHETER TUBING. THEN, USING A DENVER SHUNT CONNECTOR PIECE, THE PATIENT¿S CATHETER WAS CONNECTED TO THE NEW VALVE AND SUTURED IN PLACE. THE PATIENT WAS DRAINED SUCCESSFULLY AND SENT HOME. THE VALVE IS WORKING WITHOUT ANY FURTHER ISSUES AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450877 PLEURX PLEURAL CATHETER KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 50-7000B

    Patients

    Seq Age Sex Outcome Treatment
    1