BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 12019638 · Received June 17, 2021

    Report

    Report Number
    8030665-2021-01027
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 17, 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
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE CASSETTE DURING STEP 9 OF THEIR PD TREATMENT. THE PATIENT CONTACT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 2 OF 4 OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT CONTACT WAS ADVISED TO DISCONTINUE THE USE OF THE CYCLER AND FOLLOW UP WITH THE PATIENT¿S 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 CONTACT STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE ABSENCE OF THE CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT CONTACT STATED THAT THE FLUID LEK ORIGINATED FROM THE CASSETTE. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE LIBERTY CYCLER SET USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER. THE CYCLER WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913067 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 050-87216 21CR08041 00840861100750

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR DELFLEX PD FLUID| LIBERTY SELECT CYCLER