BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 15918789 · Received December 5, 2022

    Report

    Report Number
    0008030665-2022-01459
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 30, 2022
    Report Date
    January 18, 2023
    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
    MS, 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: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE PATIENT FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS LIBERTY CYCLER SETS SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR 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 CONTACT OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY SELECT CYCLER ALARMED WITH AN M31 AIR DETECTED IN CASSETTE WARNING DURING DWELL 1 OF 9. THE WARNING OCCURRED THREE NIGHTS (QSN # (B)(4)). THE PATIENT WAS CONNECTED DURING THE INCIDENT. FLUID WAS DISCOVERED. THE CAUSE AND SOURCE OF THE LEAK ARE UNKNOWN. TECHNICAL SUPPORT ISSUED A REPLACEMENT CYCLER DUE TO THE M31 AIR DETECTED IN CASSETTE ALARM EVEN AFTER RE-SETUP WITH NEW SUPPLIES. THE PATIENT WAS ADVISED TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) TO INFORM THEM OF THE REPLACEMENT. THE PATIENT WILL NOT PERFORM MANUAL TREATMENT AS THEY DO NOT KNOW HOW TO. UPON FOLLOWUP ON 12/05/2022, THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THEY HAD NOT BEEN MADE AWARE OF THE REPORTED EVENT BY THE PATIENT. THE PDRN CONFIRMED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN COULD NOT CONFIRM IF THE NEW CYCLER HAS BEEN RECEIVED, OR THE PREVIOUS ONE RETURNED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    A CONTACT OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY SELECT CYCLER ALARMED WITH AN M31 AIR DETECTED IN CASSETTE WARNING DURING DWELL 1 OF 9. THE WARNING OCCURRED THREE NIGHTS (QSN #8013357245, 8013361985, 8013352444). THE PATIENT WAS CONNECTED DURING THE INCIDENT. FLUID WAS DISCOVERED. THE CAUSE AND SOURCE OF THE LEAK ARE UNKNOWN. TECHNICAL SUPPORT ISSUED A REPLACEMENT CYCLER DUE TO THE M31 AIR DETECTED IN CASSETTE ALARM EVEN AFTER RE-SETUP WITH NEW SUPPLIES. THE PATIENT WAS ADVISED TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) TO INFORM THEM OF THE REPLACEMENT. THE PATIENT WILL NOT PERFORM MANUAL TREATMENT AS THEY DO NOT KNOW HOW TO. UPON FOLLOWUP ON (B)(6) 2022, THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THEY HAD NOT BEEN MADE AWARE OF THE REPORTED EVENT BY THE PATIENT. THE PDRN CONFIRMED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN COULD NOT CONFIRM IF THE NEW CYCLER HAS BEEN RECEIVED, OR THE PREVIOUS ONE RETURNED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358482 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 050-87216 00840861100750

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male DELFLEX PD SOLUTION| DELFLEX PD SOLUTION| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER