BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 12325104 · Received August 16, 2021

    Report

    Report Number
    8030665-2021-01314
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 10, 2021
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100750
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK IN THE PUMP MODULE AREA OF THE CYCLER AND ON THE EXTERNAL OF THE CASSETTE AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN MWD WATCHDOG TIMER ERROR ALARM AND AN AIR DETECTED IN CASSETTE WARNING DURING FILL 4 OF 6. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONFIRMED THE REPORTED EVENT. THE PATIENT RECEIVED A MWD WATCHDOG TIMER ERROR ALARM AND AN AIR DETECTED IN CASSETTE WARNING DURING FILL 4 OF 6 AND TREATMENT WAS CANCELLED. UPON OPENING THE CASSETTE DOOR, THERE WAS FLUID LEAKING OUT. THE FLUID LEAK OCCURRED BETWEEN THE CASSETTE AND THE CASSETTE DOOR. THE PATIENT STATED THAT THE BAG WAS NOT LEAKING AND CONFIRMED THAT THE BAG DID NOT HAVE ANY ISSUES. THE CAUSE OF THE LEAK WAS UNKNOWN. THERE WERE NO OTHER FLUID LEAKS WERE FOUND. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT ON THE NIGHT OF THE REPORTED EVENT. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CASSETTE USED BY THE PATIENT IS AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    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 DISCOVERED A FLUID LEAK IN THE PUMP MODULE AREA OF THE CYCLER AND ON THE EXTERNAL OF THE CASSETTE AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN MWD WATCHDOG TIMER ERROR ALARM AND AN AIR DETECTED IN CASSETTE WARNING DURING FILL 4 OF 6. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONFIRMED THE REPORTED EVENT. THE PATIENT RECEIVED A MWD WATCHDOG TIMER ERROR ALARM AND AN AIR DETECTED IN CASSETTE WARNING DURING FILL 4 OF 6 AND TREATMENT WAS CANCELLED. UPON OPENING THE CASSETTE DOOR, THERE WAS FLUID LEAKING OUT. THE FLUID LEAK OCCURRED BETWEEN THE CASSETTE AND THE CASSETTE DOOR. THE PATIENT STATED THAT THE BAG WAS NOT LEAKING AND CONFIRMED THAT THE BAG DID NOT HAVE ANY ISSUES. THE CAUSE OF THE LEAK WAS UNKNOWN. THERE WERE NO OTHER FLUID LEAKS WERE FOUND. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT ON THE NIGHT OF THE REPORTED EVENT. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CASSETTE USED BY THE PATIENT IS AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223919 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 050-87216 18LR08037 00840861100750

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER| DELFLEX PD FLUID| LIBERTY SELECT CYCLER