BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PLEURX CATHETER

    MDR report key: 20315349 · Received September 26, 2024

    Report

    Report Number
    1625685-2024-00110
    Event Type
    Death
    Date Received
    September 26, 2024
    Date of Event
    September 13, 2024
    Report Date
    November 20, 2024
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A24. PATIENT PROBLEM CODE: F02. H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. A PHOTO OF THE DEFECT COULD ASSIST OUR QUALITY TEAM IN THEIR INVESTIGATION. WE ARE UNABLE TO IDENTIFY AN ADVERSE EVENT OR UNABLE TO DETERMINE THE RELATIONSHIP ASSOCIATED WITH THE PRODUCT THAT WOULD HAVE CONTRIBUTED PATIENT DEATH. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. H10: G4. H11: H6 (RESULT, CONCLUSION). H11. : SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY SEVEN MONTHS POST CATHETER PLACEMENT, THE PATIENT EXPERIENCED AN ALLEGED INFECTION. THE PATIENT EXPIRED. THE RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE DEVICES USED WAS NOT PROVIDED. ON THU 09/19/2024 ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR. CAN YOU PLEASE CONFIRM THE CATHETER PLACED WAS PLEURX CATHETER? - EITHER 50-7050 OR 50-9050A. IF YES, CAN THE CUSTOMER CONFIRM THE PLEURX DEVICE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH? PLEASE EXPLAIN- FAMILY MEMBER DOES NOT WANT TO MAKE A STATEMENT. IS THERE A PRODUCT FAILURE THAT IS CLAIMED WITH REGARDS TO THE DEATH, OR WAS THE PATIENT ONLY UNDER PALLIATIVE CARE AND THE DEATH IS TIED TO HIS/HER UNDERLYING CONDITIONS? AS THE PATIENT ALREADY HAD THE CATHETER IMPLANTED IN (B)(6) 2024, WE DO ASSUME THAT THE PRODUCT IN QUESTION WAS NOT RESPONSIBLE FOR THE DEATH. LOT NUMBER AND MATERIAL NUMBER ASSOCIATED WITH REPORTED DEATH. NOT KNOWN. CAN THE CUSTOMER PROVIDE A DEATH CERTIFICATE; AUTOPSY REPORT; PATHOLOGY REPORT; AND/OR CLINICAL PROCEDURAL NOTES? NO. ARE ANY IMAGES OR PHOTOS AVAILABLE FOR REVIEW? IF YES, PLEASE PROVIDE. - NO. WHEN WAS THE INFECTION FIRST IDENTIFIED. NOT KNOWN. DATE OF EVENT FOR THE INFECTION. NOT KNOWN. DATE OF DEATH? (B)(6) 2024. IT WAS REPORTED THAT THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, IS THIS CORRECT? YES THIS IS CORRECT. REGRADING TO INFECTION, WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? NOT KNOWN. WHERE WAS THE CATHETER LOCATED? ABDOMEN OR CHEST. NOT KNOWN. WAS THE DEVICE FUNCTIONING AS INTENDED AT THE TIME OF PATIENT DEATH? NOT KNOWN CAN YOU PLEASE PROVIDE PATIENT¿S AGE, WEIGHT, GENDER, ETHNICITY AND OR RACE. AGE: 76. IF THE DEVICE EXPLANTED FORM THE PATIENT, PLEASE PROVIDE EXPLANTED DATE. HOW LONG HAS THE CATHETER BEEN IN PLACE, PLEASE PROVIDE PLEURX CATHETER IMPLANTATION DATE. (B)(6) 2024. WAS THE DEVICE BEING MAINTAINED ACCORDING TO THE INSTRUCTION FOR USE? NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY SEVEN MONTHS POST CATHETER PLACEMENT, THE PATIENT EXPERIENCED AN ALLEGED INFECTION. THE PATIENT EXPIRED. THE RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE DEVICES USED WAS NOT PROVIDED. RESPONSE RECEIVED ON 19-SEP-2024. CAN YOU PLEASE CONFIRM THE CATHETER PLACED WAS PLEURX CATHETER? - EITHER 50-7050 OR 50-9050A. IF YES, CAN THE CUSTOMER CONFIRM THE PLEURX DEVICE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH? PLEASE EXPLAIN- FAMILY MEMBER DOES NOT WANT TO MAKE A STATEMENT IS THERE A PRODUCT FAILURE THAT IS CLAIMED WITH REGARDS TO THE DEATH, OR WAS THE PATIENT ONLY UNDER PALLIATIVE CARE AND THE DEATH IS TIED TO HIS/HER UNDERLYING CONDITIONS? -AS THE PATIENT ALREADY HAD THE CATHETER IMPLANTED IN FEBRUARY, WE DO ASSUME THAT THE PRODUCT IN QUESTION WAS NOT RESPONSIBLE FOR THE DEATH. LOT NUMBER AND MATERIAL NUMBER ASSOCIATED WITH REPORTED DEATH. NOT KNOWN CAN THE CUSTOMER PROVIDE A DEATH CERTIFICATE; AUTOPSY REPORT; PATHOLOGY REPORT; AND/OR CLINICAL PROCEDURAL NOTES? NO. ARE ANY IMAGES OR PHOTOS AVAILABLE FOR REVIEW? IF YES, PLEASE PROVIDE. NO. WHEN WAS THE INFECTION FIRST IDENTIFIED. NOT KNOWN. DATE OF EVENT FOR THE INFECTION. NOT KNOWN. DATE OF DEATH? (B)(6) 2024. IT WAS REPORTED THAT THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, IS THIS CORRECT? YES THIS IS CORRECT. REGRADING TO INFECTION, WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? NOT KNOWN. WHERE WAS THE CATHETER LOCATED? ABDOMEN OR CHEST. NOT KNOWN. WAS THE DEVICE FUNCTIONING AS INTENDED AT THE TIME OF PATIENT DEATH? NOT KNOWN. CAN YOU PLEASE PROVIDE PATIENT¿S AGE, WEIGHT, GENDER, ETHNICITY AND OR RACE. AGE: 76. IF THE DEVICE EXPLANTED FORM THE PATIENT, PLEASE PROVIDE EXPLANTED DATE. HOW LONG HAS THE CATHETER BEEN IN PLACE, PLEASE PROVIDE PLEURX CATHETER IMPLANTATION DATE. (B)(6) 2024. WAS THE DEVICE BEING MAINTAINED ACCORDING TO THE INSTRUCTION FOR USE? ¿ NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371390 UNKNOWN PLEURX CATHETER APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Death