BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 15640124 · Received October 20, 2022

    Report

    Report Number
    0008030665-2022-01219
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    October 5, 2022
    Report Date
    November 15, 2022
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100750
    PMA / PMN Number
    K173718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    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-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

    A PERITONEAL DIALYSIS (PD) PATIENT'S CARETAKER REPORTED THAT A PATIENT ENCOUNTERED A FLUID LEAK DURING PD TREATMENT. DURING DRAIN 1 OF 5 THERE WAS A WARNING OF AIR DETECTED IN CASSETTE. FLUID WAS DISCOVERED IN THE PUMP MODULE AREA AND ON EXTERNAL PART OF CASSETTE. IN A FOLLOW UP, THE CARETAKER CONFIRMED THE REPORTED EVENT AND STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CARETAKER CONFIRMED THAT THE PATIENT HAS RECEIVED A REPLACEMENT CYCLER AND IS CONTINUING WITH PERITONEAL DIALYSIS ON THE NEW CYCLER WITHOUT ISSUE. THE CYCLER IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT'S CARETAKER REPORTED THAT A PATIENT ENCOUNTERED A FLUID LEAK DURING PD TREATMENT. DURING DRAIN 1 OF 5 THERE WAS A WARNING OF AIR DETECTED IN CASSETTE. FLUID WAS DISCOVERED IN THE PUMP MODULE AREA AND ON EXTERNAL PART OF CASSETTE. IN A FOLLOW UP, THE CARETAKER CONFIRMED THE REPORTED EVENT. STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CARETAKER CONFIRMED THAT THE PATIENT HAS RECEIVED A REPLACEMENT CYCLER AND IS CONTINUING WITH PERITONEAL DIALYSIS ON THE NEW CYCLER WITHOUT ISSUE. THE CYCLER SET WAS DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CYCLER IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2820177 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 050-87216 22DR08046 00840861100750

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER