BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 8642240 · Received May 24, 2019

    Report

    Report Number
    8030665-2019-00798
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    April 9, 2019
    Report Date
    August 30, 2019
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100736
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: FURTHER INFORMATION REVEALED THAT CULTURE RESULTS FOR 27 PATIENTS GREW GRAM NEGATIVE BACTERIA (SERRATIA, KLEBSIELLA, ENTEROBACTER, PSEUDOMONAS), CULTURE RESULTS FOR 3 PATIENTS GREW STAPHYLOCOCCUS AUREUS, CULTURE RESULT FOR 1 PATIENT GREW STAPHYLOCOCCUS EPIDERMIS, AND CULTURE RESULTS FOR 4 PATIENTS REMAIN UNKNOWN. FURTHER INFORMATION REGARDING THE EVENTS HAS BEEN DECLINED TO BE PROVIDED.

    Additional Manufacturer Narrative · 0

    CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN PD THERAPY UTILIZING THE LIBERTY SELECT CYCLER/LIBERTY CYCLER SET AND THE PATIENT¿S ENTEROBACTER CLOACAE PERITONITIS EVENT. HOWEVER, CURRENTLY THERE IS NO OBJECTIVE EVIDENCE THAT A LIBERTY SELECT CYCLER/LIBERTY CYCLER SET PRODUCT ISSUE CAUSED OR CONTRIBUTED TO THE EVENT. PERITONITIS IS A WELL-KNOWN POTENTIAL COMPLICATION IN PD PATIENTS WHICH CAN BE A RESULT OF MULTIPLE POTENTIAL ETIOLOGIES. THE CAUSE OF THE PATIENT¿S PERITONITIS CANNOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE. HOWEVER, THE PATIENT HAD CONCOMITANT CONSTIPATION WHICH INCREASES THE PATIENT¿S SUSCEPTIBILITY FOR PERITONITIS INFECTION. MOREOVER, THE PATIENT¿S PD EFFLUENT GREW ENTEROBACTER SPECIES WHICH IS A KNOWN BACTERIUM THAT IS OFTEN ASSOCIATED WITH PERITONITIS CAUSED BY TOUCH CONTAMINATION. ADDITIONALLY, THE CAREGIVER/PATIENT WAS RELATIVELY NEW TO USING FRESENIUS PRODUCTS FOR PD THERAPY. THE NATURE AND DEGREE OF CAREGIVER/ PATIENT TRAINING ON FRESENIUS PRODUCTS AS WELL AS PATIENT PROFICIENCY WITH THE NEW PROCEDURE IS UNKNOWN. ACCORDING TO THE INTERNATIONAL SOCIETY OF PERITONEAL DIALYSIS (ISPD) GUIDELINES, PATIENT TRAINING AND EDUCATION IS A CRITICAL COMPONENT IN PREVENTION OF PD-RELATED PERITONITIS AS WELL AS RE-TRAINING ESPECIALLY FOLLOWING A CHANGE TO ANOTHER SUPPLIER OR A DIFFERENT TYPE OF CONNECTION.

    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. ONE CASE OF ALTERNATE SAMPLES WAS RETRIEVED FROM THE DISTRIBUTION CENTER WITH PRODUCT NUMBER 050-87212 AND LOT NUMBER 19AR08126. DURING THE EVALUATION A VISUAL AND FUNCTIONAL TEST OF THE ALTERNATE SAMPLES WERE PERFORMED, AND RESULTS WERE ACCEPTABLE. THE SAMPLE WAS TESTED IN THE CYCLER MACHINE AND WORKED AS INTENDED WITHOUT ANY ABNORMALITIES. 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 OF THE ACTUAL DEVICE 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

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS FOLLOWING TRANSITION TO FRESENIUS PRODUCTS. THE NATURE AND DEGREE OF PATIENT TRAINING AS WELL AS PATIENT UNDERSTANDING AND ADHERENCE TO PROCEDURE IS UNKNOWN. THE PATIENT DOES PERFORM A DAYTIME MANUAL EXCHANGE. A CULTURE TEST WAS PERFORMED, AND THE RESULTS CONFIRMED GROWTH OF ENTEROBACTER CLOACAE. THE PATIENT HAD EXPERIENCED CONSTIPATION. THE PATIENT¿S SPOUSE ASSISTS WITH PERFORMING PD EXCHANGES. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE, DOSE, ROUTE, FREQUENCY UNKNOWN). ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

    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 WAS DIAGNOSED WITH PERITONITIS. A CULTURE WAS OBTAINED WHICH CONFIRMED THE DIAGNOSIS OF PERITONITIS, HOWEVER THE ORGANISM WAS UNKNOWN. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE, DOSE, ROUTE, DURATION UNKNOWN). ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER TO DATE NOT PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE REASSESSED AND UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435794 LIBERTY CYCLER SET, DUAL PATIENT CONNECT SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 00840861100736

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER| DELFLEX PD FLUID| LIBERTY SELECT CYCLER