BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 9125512 · Received September 26, 2019

    Report

    Report Number
    8030665-2019-01529
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 16, 2019
    Report Date
    October 2, 2019
    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
    MS, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CLINICAL REVIEW: THE FILE WAS ASSESSED TO DETERMINE WHETHER A CLINICAL INVESTIGATION IS WARRANTED. ON (B)(6) 2019, FMCRTG, LLC BECAME AWARE THIS (B)(6) MALE PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] FOR RENAL REPLACEMENT THERAPY SINCE (B)(6) 2015 WAS HOSPITALIZED FROM (B)(6) 2019 THROUGH (B)(6) 2019 DUE TO COMMUNITY ACQUIRED PNEUMONIA. THE DISCHARGE SUMMARY WAS UNAVAILABLE DURING THE CALL. THE PDRN REPORTED THAT THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC (DRUG, DOSE, ROUTE, DURATION AND FREQUENCY NOT PROVIDED) AND WAS DISCHARGED IN STABLE CONDITION. THE PATIENT CONTINUED TO UNDERGO CCPD THERAPY WHILE HOSPITALIZED UTILIZING FRESENIUS PRODUCTS. THE PDRN STATED THE EVENT WAS UNRELATED TO THE UTILIZATION OF THE LIBERTY SELECT CYCLER, LIBERTY CYCLER SET OR ANY FRESENIUS DEVICE(S) OR PRODUCT(S). DUE TO THE PATIENT¿S LIMITED MOBILITY, RECOVERY HAS BEEN PROLONGED BUT THE PATIENT IS IMPROVING. BASED ON THE INFORMATION AVAILABLE, THE LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET ARE DISASSOCIATED FROM THE EVENT, AS THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS PRODUCT DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT OR HOSPITALIZATION. THEREFORE, THE COMPLETION OF A CLINICAL INVESTIGATION IS NOT WARRANTED AT THIS TIME. 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 CAREGIVER FOR A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE INSIDE OF THE CASSETTE DOOR OF THE PATIENT'S CYCLER AFTER ENDING THEIR PD TREATMENT. THE CAREGIVER REPORTED RECEIVING A PATIENT LINE IS BLOCKED (SOFT ALARM) AND AN AIR DETECTED IN CASSETTE ALARM DURING TREATMENT THE PREVIOUS NIGHT AND THE TREATMENT WAS CANCELLED. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE CAREGIVER 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, IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL. ADDITIONAL FOLLOW UP WITH THE PATIENT¿S PDRN REVEALED THAT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2019 THROUGH (B)(6) 2019 DUE TO COMMUNITY ACQUIRED PNEUMONIA (UNRELATED TO PD THERAPY). THE DISCHARGE SUMMARY WAS UNAVAILABLE DURING THE CALL. THE PDRN REPORTED THAT THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC (DRUG, DOSE, ROUTE, DURATION AND FREQUENCY NOT PROVIDED) AND WAS DISCHARGED IN STABLE CONDITION. THE PATIENT CONTINUED TO UNDERGO CONTINUOUS CYCLIC PERITONEAL DIALYSIS (CCPD) THERAPY WHILE HOSPITALIZED UTILIZING FRESENIUS PRODUCTS. THE PDRN STATED THE EVENT WAS UNRELATED TO THE UTILIZATION OF THE LIBERTY SELECT CYCLER, LIBERTY CYCLER SET OR ANY FRESENIUS DEVICE(S) OR PRODUCT(S). DUE TO THE PATIENT¿S LIMITED MOBILITY, RECOVERY HAS BEEN PROLONGED BUT THE PATIENT IS IMPROVING. THE CASSETTE USED BY THE PATIENT DURING THE FLUID LEAK WAS REPORTED TO BE AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER. THE CYCLER WAS SCHEDULED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919146 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 00840861100750

    Patients

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