BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 8663984 · Received June 3, 2019

    Report

    Report Number
    8030665-2019-00835
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 20, 2019
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100736
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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-CONFORMANCE'S 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.

    Additional Manufacturer Narrative · 0

    REPORT SOURCE SHOULD INCLUDE CONSUMER.

    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 ON THE INSIDE OF THE CASSETTE DOOR IN DRAIN 3 OF 4 DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 3 OF 4 OF TREATMENT AND THE TREATMENT WAS CANCELLED. 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, MANUALS WAS AVAILABLE. UPON FOLLOW UP, THE PDRN STATED THAT THEY DID NOT HAVE ANY INFORMATION ON THE REPORTED EVENT. THE CYCLER WAS SCHEDULED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456856 LIBERTY CYCLER SET, DUAL PATIENT CONNECT SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 19BR08060 00840861100736

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR DELFLEX PD FLUID| LIBERTY SELECT CYCLER| DELFLEX PD FLUID| LIBERTY SELECT CYCLER