BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLEURX PLEURAL CATHETER MINI KIT

    MDR report key: 2233442 · Received September 2, 2011

    Report

    Report Number
    1625685-2011-00017
    Event Type
    Death
    Date Received
    September 2, 2011
    Date of Event
    May 20, 2011
    Report Date
    August 8, 2011
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K052436
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE (1) UNOPENED SAMPLE BELONGING TO THE SAME LOT USED IN THE REPORTED COMPLAINT WAS PROVIDED FOR EVALUATION. EVALUATION OF THE SUBMITTED SAMPLE DID NOT REVEAL ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. A 24-MONTH REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURE MODES. A THOROUGH REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A DEVICE HISTORY REVIEW (DHR), RAW MATERIAL HISTORY FILES, AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOT SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE FOR THIS FAILURE MODE WAS IDENTIFIED AS USER ERROR DURING THE PLACEMENT OF THE PLEURAL CATHETER IN THE AFFECTED PATIENT. IT IS THE RECOMMENDATION OF THIS INVESTIGATION FOR THE USER OF THIS DRAINAGE SYSTEM TO MINIMIZE THE POTENTIAL RISK FOR CATHETER MISPLACEMENT TO USE IMAGE GUIDANCE TO VERIFY PROPER CATHETER PLACEMENT. FOLLOW CURRENT GENERAL GUIDELINES INDICATED IN THE PRODUCT DIRECTIONS FOR USE FOR ACCURACY AND SAFETY OF CATHETER PLACEMENT WHEN USING THIS SYSTEM. BASED ON FEEDBACK REGARDING CLINICIAN PREFERENCES, A SHORTER ADAPTER AND PEEL AWAY SHEATH HAVE BEEN IMPLEMENTED UNDER PROJECT (B)(6). THESE PREVENTIVE ACTIONS WERE IMPLEMENTED IN (B)(6) 2011, AFTER THE MANUFACTURE OF LOT L0L272.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO CAREFUSION (B)(4): THE PROCEDURE HAPPENED ON (B)(6) 2011. THE PATIENT DEVELOPED SEVERE SUBCUTANEOUS EMPHYSEMA IN THE WEEK AFTER, AND ALSO HAD FIBRINOLYTIC INSTILLED INTO HIS LUNG (HE COUGHED IT UP IN THE HOURS AFTERWARDS) BEFORE THE PHYSICIAN KNEW THE CATHETER WAS IN THE LUNG. IN THE END, FORTUNATELY THE CATHETER TIP IN THE LUNG MUST HAVE BECOME OBSTRUCTED BY PATIENT SECRETIONS OR FIBRIN, AS THE AIR LEAK STOPPED AROUND 9 DAYS AFTER THE PROCEDURE. AROUND 5 CMS OF DISTAL CATHETER WAS IN THE LUNG, WITH MOST OF THE CATHETER SIDE-HOLES STILL IN THE PLEURAL SPACE AND DRAINING THE EFFUSION. THE PATIENT HAD A VERY LOCULATED BUT RAPIDLY ACCUMULATING EFFUSION AND BECAUSE OF SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) HE WOULD DEVELOP RESPIRATORY FAILURE IF THE FLUID BUILT UP EXCESSIVELY. BECAUSE OF THE LOCATION OF THE CATHETER IN THE LUNG, THEY PHYSICIAN HAD TO STOP THE INTRAPLEURAL FIBRINOLYTIC, BUT THE CATHETER DID HAVE FREE CONTINUOUS DRAINAGE IN THE DAYS AFTER THE TIP BLOCKED. EXTENSIVE FIBRIN WAS PROBABLY BLOCKING THE REMAINING CATHETER IN THE PLEURAL SPACE, BUT IT WAS DIFFICULT TO PREVENT THIS, AS THEY WERE CONCERNED THAT FLUSHING MAY UNBLOCK THE TIP IN THE LUNG. THE PATIENT WAS NOT SUITABLE FOR SURGERY AND HE WENT HOME WITH PALLIATIVE CARE SUPPORT ON (B)(6) 2011 AND DIED WITHIN 1 WEEK AT HOME, WITH THE CATHETER STILL IN PLACE. ATTEMPTS WERE MADE TO CONTACT THE PATIENT'S SON TO FIND OUT WHETHER THE CATHETER WAS STILL DRAINING FLUID AS HE DIED. THE PHYSICIAN SUSPECTS THIS COMPLICATION AS A SMALL CONTRIBUTING FACTOR TO THE TIMING OF THE PATIENT'S DEATH; BECAUSE OF THE SEVERITY OF HIS MALIGNANT PLEURAL DISEASE COMBINED WITH SEVERE COPD, HE MAY HAVE DIED AT A SIMILAR TIME, OR A FEW MONTHS LATER, IF THIS COMPLICATION HAD NOT HAPPENED. THE PHYSICIAN INDICATED THAT THE LONGER INTRODUCER LEAD TO THE CATHETER BEING INSERTED INTO THE LUNG. THIS WAS INSERTED BY A HIGHLY EXPERIENCED INTERVENTIONAL RADIOLOGIST, IN A RELATIVELY TECHNICALLY DIFFICULT PROCEDURE, AS THE PATIENT HAD A LOCULATED EFFUSION. THE LOT NUMBER IS UNKNOWN, HOWEVER, A LOT THAT MAY POSSIBLY BE INVOLVED WAS REPORTED. A SAMPLE FROM THAT SAME LOT IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX PLEURAL CATHETER MINI KIT PLEURAL CATHETER MINI KIT DWM CAREFUSION 50-7050 L0L272

    Patients

    Seq Age Sex Outcome Treatment
    1 Death