BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 11865793 · Received May 21, 2021

    Report

    Report Number
    2937457-2021-01097
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    November 27, 2019
    Report Date
    June 3, 2021
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT HAD A HERNIA. UPON FOLLOW UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED A (PD) CATHETER WAS PLACED ON (B)(6) 2019. THE PATIENT HAD NOT YET STARTED PD THERAPY WHEN DIAGNOSED BY A SURGEON WITH A HERNIA. THE PATIENT WAS SEEN AGAIN BY A SURGEON ON (B)(6) 2019 WHEN IT WAS DOCUMENTED IN THE PATIENT¿S RECORD THAT SHE HAS A LEFT UPPER ABDOMINAL VENTRAL HERNIA. THE PATIENT CHOSE NOT TO HAVE A SURGICAL REPAIR AND JUST REST THE ABDOMEN AS THE PATIENT HAD REFUSED TO UNDERGO HEMODIALYSIS (HD). THE PDRN STATED THAT THE PATIENT¿S RECORD DOCUMENTS A SURGICAL REPAIR OF THE HERNIA ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED RELATED TO THE HERNIA. THE PDRN REPORTED THE PATIENT HAS POLYCYSTIC KIDNEY DISEASE (PKD) WHICH INCREASES THE RISK FOR DEVELOPING HERNIAS. THE PDRN STATED THE HERNIA IS UNRELATED TO USE OF THE LIBERTY SELECT CYCLER OR OTHER FRESENIUS PRODUCT(S) AND IT IS A RESULT OF THE PKD. THE PATIENT HAS NOT REQUIRED ANY CHANGE IN PD PRESCRIPTION AS A RESULT OF THE HERNIA.

    Additional Manufacturer Narrative · 1

    CLINICAL INVESTIGATION: THERE IS NO TEMPORAL RELATIONSHIP BETWEEN PD THERAPY UTILIZING THE LIBERTY SELECT CYCLER AND THE PATIENT EVENT OF HERNIA AS THE HERNIA WAS DIAGNOSED PRIOR TO THE PATIENT INITIATING PD THERAPY. THERE IS ALSO NO DOCUMENTATION IN THE COMPLAINT FILE TO SHOW A CAUSAL RELATIONSHIP BETWEEN THE HERNIA AND UTILIZATION OF THE LIBERTY SELECT CYCLER. PER THE PDRN, THE PATIENT HAS POLYCYSTIC KIDNEY DISEASE PUTTING THE PATIENT AT INCREASED RISK FOR HERNIA DEVELOPMENT AND THIS HAS BEEN ATTRIBUTED AS THE CAUSE OF THE HERNIA. EPISODES OF ABDOMINAL HERNIA APPEARED STATISTICALLY MORE OFTEN IN PKD PATIENTS TREATED WITH PD\; HOWEVER, ABDOMINAL WALL COMPLICATIONS HAVE BEEN FOUND TO BE MORE FREQUENT IN PKD PATIENTS AT ALL STAGES OF KIDNEY DISEASE INCLUDING BEFORE END STAGE RENAL DISEASE. THIS HERNIA WAS DIAGNOSED AFTER PLACEMENT OF THE PD CATHETER AND PRIOR TO START OF THERAPY. BASED ON THE AVAILABLE INFORMATION, THE LIBERTY SELECT CYCLER CAN BE EXCLUDED AS THE CAUSE OF THE PATIENT¿S HERNIA. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT HAD A HERNIA. UPON FOLLOW UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED A (PD) CATHETER WAS PLACED ON (B)(6) 2019. THE PATIENT HAD NOT YET STARTED PD THERAPY WHEN DIAGNOSED BY A SURGEON WITH A HERNIA. THE PATIENT WAS SEEN AGAIN BY A SURGEON ON (B)(6) 2019 WHEN IT WAS DOCUMENTED IN THE PATIENT¿S RECORD THAT SHE HAS A LEFT UPPER ABDOMINAL VENTRAL HERNIA. THE PATIENT CHOSE NOT TO HAVE A SURGICAL REPAIR AND JUST REST THE ABDOMEN AS THE PATIENT HAD REFUSED TO UNDERGO HEMODIALYSIS (HD). THE PDRN STATED THAT THE PATIENT¿S RECORD DOCUMENTS A SURGICAL REPAIR OF THE HERNIA ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED RELATED TO THE HERNIA. THE PDRN REPORTED THE PATIENT HAS POLYCYSTIC KIDNEY DISEASE (PKD) WHICH INCREASES THE RISK FOR DEVELOPING HERNIAS. THE PDRN STATED THE HERNIA IS UNRELATED TO USE OF THE LIBERTY SELECT CYCLER OR OTHER FRESENIUS PRODUCT(S) AND IT IS A RESULT OF THE PKD. THE PATIENT HAS NOT REQUIRED ANY CHANGE IN PD PRESCRIPTION AS A RESULT OF THE HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763822 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 180343 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention DELFLEX PD FLUID.| DELFLEX PD FLUID.| LIBERTY CYCLER SET. | LIBERTY CYCLER SET.