BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 8739426 · Received June 27, 2019

    Report

    Report Number
    8030665-2019-00964
    Event Type
    Death
    Date Received
    June 27, 2019
    Date of Event
    April 8, 2019
    Report Date
    July 19, 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

    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

    CLINICAL REVIEW: ALTHOUGH FRESENIUS RTG, LLC DOCUMENTATION SHOWS THIS PATIENT WAS SHIPPED PD PRODUCTS, THE PROVIDED PATIENT INFORMATION STATED THE PATIENT HAD NOT TRANSITIONED TO FRESENIUS PRODUCTS AND THAT THE PATIENT WAS STILL UTILIZING BAXTER PRODUCTS. THERE IS NO DOCUMENTATION TO SHOW A CAUSAL RELATIONSHIP BETWEEN THE PATIENT PERITONITIS AND DEATH WITH MULTIPLE CONCOMITANT DIAGNOSES INCLUDING PERINEPHRIC ABSCESS AND THE LIBERTY CYCLER SET. ADDITIONALLY, THERE IS NO ALLEGATION OF A DEFECT REPORTED FOR THE LIBERTY CYCLER SET IN RELATION TO THIS EVENT. IT WAS DOCUMENTED THAT THE PATIENT WAS ADMINISTERED ANTIBIOTIC THERAPY FOR THE PERITONITIS. THE PD EFFLUENT CULTURE RESULTED IN NO GROWTH AT THAT TIME. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON AN UNKNOWN DATE AND RECEIVED HOSPICE SERVICES PRIOR TO DEATH. IT CANNOT BE CONFIRMED IF THE PERITONITIS IS CONNECTED TO THE HOSPITALIZATION. THE PATIENT DID HAVE A CONCOMITANT DIAGNOSIS OF PERINEPHRIC ABSCESS, LACTOCOCCUS IN ORIGIN, WHICH TENDS TO PRESENT WITH SIMILAR SYMPTOMS AS PERITONITIS, SUCH AS ABDOMINAL PAIN, FEVER, LETHARGY AND GASTROINTESTINAL (GI) SYMPTOMS WITH A HIGH MORTALITY RATE OF UP TO 65% DUE TO DELAYED DIAGNOSIS AS SYMPTOMS ARE INSIDIOUS. END STAGE RENAL DISEASE PATIENTS IN GENERAL ARE AT INCREASED RISK FOR INFECTION DUE TO BEING IMMUNOCOMPROMISED WHICH IS COMPOUNDED BY THEIR COMORBID CONDITIONS. IT IS UNKNOWN IF THE PATIENT¿S PERITONITIS WAS RELATED TO THE HOSPITALIZATION AND IT IS UNKNOWN WHEN THE PATIENT WITHDREW FROM DIALYSIS TREATMENT AND TRANSITIONED TO HOSPICE. IN ADDITION TO THE PERINEPHRIC ABSCESS, THE PATIENT¿S OTHER CONCOMITANT DIAGNOSES ALL PUT THE PATIENT AT INCREASED RISK FOR MORTALITY. BASED ON THE AVAILABLE INFORMATION, THERE IS NO OBJECTIVE EVIDENCE THAT A LIBERTY CYCLER SET OR ANY FRESENIUS PRODUCT DEFICIENCY OR MALFUNCTION CAUSED THE PATIENT¿S PERITONITIS, ADDITIONAL CONCOMITANT DIAGNOSES AND SUBSEQUENT DEATH. ADDITIONALLY, THERE IS NO DOCUMENTATION THAT THE PATIENT UTILIZED ANY FRESENIUS PRODUCT(S) FOR PD THERAPY.

    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 EXPERIENCED PERITONITIS. A CULTURE TEST WAS PERFORMED, HOWEVER THERE WAS NO GROWTH. IT WAS REPORTED THAT THE PATIENT DID NOT TRANSITION TO FRESENIUS PRODUCTS, HOWEVER A PRODUCT HISTORY SEARCH CONFIRMED THAT FRESENIUS PRODUCTS WERE DELIVERED TO THIS PATIENT. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE, DOSE, ROUTE, FREQUENCY UNKNOWN). THE PATIENT RECEIVED HOSPICE SERVICES IN THE HOSPITAL (DETAILS UNKNOWN). THE PATIENT EXPIRED ON AN UNKNOWN DATE (DETAIL UNKNOWN). ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534728 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 Death| H| R DELFLEX PD FLUID| LIBERTY SELECT CYCLER| DELFLEX PD FLUID| LIBERTY SELECT CYCLER