BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMC CASSETTE

    MDR report key: 20426746 · Received October 11, 2024

    Report

    Report Number
    0008030665-2024-00867
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 25, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    PMA / PMN Number
    K173718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN CCPD THERAPY UTILIZING THE LIBERTY CYCLER SET AND THE ADVERSE EVENT OF PERITONITIS, CHARACTERIZED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT FLUID. IT IS WELL ESTABLISHED THAT PD PATIENTS ARE AT HIGH RISK FOR INFECTIONS OF THE PERITONEUM (1). THE ROOT CAUSE OF THIS PATIENT¿S PERITONITIS CAN BE ATTRIBUTED TO A BREAK IN ASEPTIC TECHNIQUE DURING CCPD THERAPY AS REPORTED BY A MEDICAL PROFESSIONAL. NONADHERENCE TO ASEPSIS DURING PD THERAPY IS THE LEADING SOURCE OF TRANSMISSION OF PERITONITIS CAUSING PATHOGENS (2). THOUGH LABORATORY RESULTS WERE NOT AVAILABLE, A REDUCTION IN SYMPTOMS IN RESPONSE TO ANTIBIOTIC THERAPY PROVIDED EVIDENCE OF A RESOLVING PERITONITIS INFECTION (2). THEREFORE, THE LIBERTY CYCLER SET CAN BE EXCLUDED AS A ROOT CAUSE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO ALLEGATION OR OBJECTIVE EVIDENCE OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THIS PATIENT¿S ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    CORRECTION: B2 (REQUIRED INTERVENTION) PLANT INVESTIGATION: 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

    ON (B)(6) 2024, IT WAS REPORTED THAT THIS PATIENT ON PERITONEAL DIALYSIS (PD) WAS GOING TO THE TO THE HOSPITAL DUE TO A POSSIBLE INFECTION. THE PATIENT ALSO STATED THAT THE SOLUTION BAGS WERE CLOUDY AND HAD SOME BOWL ISSUES LEADING UP TO THIS. THIS PATIENT STARTED HAVING PAIN LAST NIGHT. IN ADDITIONAL FOLLOW-UP IT WAS DISCOVERED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 FOLLOWING ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID FOR THE PAST THREE PD TREATMENTS PRIOR TO HOSPITALIZATION. IT WAS EXPLAINED THAT THE PATIENT¿S REPORT OF CLOUDY BAGS ONLY REFERRED TO THEIR DRAIN BAGS AFTER PD TREATMENTS (INDICATING INFECTION) AND NOT OUT-OF-BOX DELFLEX SOLUTION BAGS. LABORATORY TESTING CONDUCTED IN THE HOSPITAL WAS NOT COMPLETED DUE TO THE SHORT TIME THE PATIENT WAS HOSPITALIZED AT THE TIME OF FOLLOW-UP. THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE DURING CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) THERAPY ON THE LIBERTY SELECT CYCLER AT HOME. THE PATIENT WAS PRESCRIBED ANTIBIOTICS WHILE HOSPITALIZED TO ADDRESS THE INFECTION, BUT THE TYPES, ROUTES AND DOSAGES WERE NOT REPORTED. IT WAS BELIEVED THE PATIENT WAS ABLE TO UNDERGO CCPD THERAPY ON A HOSPITAL PROVIDED CYCLER (UNKNOWN BRAND AND MODEL) FOR THE DURATION OF THE ADMISSION. THE PATIENT IS RECOVERING FROM THIS EVENT WHILE AWAITING DISCHARGE TO HOME. IT WAS CONFIRMED THE PATIENT¿S PERITONITIS AND ASSOCIATED HOSPITALIZATION WERE NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE PATIENT PLANS TO CONTINUE CCPD THERAPY ON THE SAME LIBERTY SELECT CYCLER AT HOME UPON DISCHARGE.

    Description of Event or Problem · 0

    ON 25/SEP/2024, IT WAS REPORTED THAT THIS PATIENT ON PERITONEAL DIALYSIS (PD) WAS GOING TO THE TO THE HOSPITAL DUE TO A POSSIBLE INFECTION. THE PATIENT ALSO STATED THAT THE SOLUTION BAGS WERE CLOUDY AND HAD SOME BOWL ISSUES LEADING UP TO THIS. THIS PATIENT STARTED HAVING PAIN LAST NIGHT. IN ADDITIONAL FOLLOW-UP IT WAS DISCOVERED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 FOLLOWING ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID FOR THE PAST THREE PD TREATMENTS PRIOR TO HOSPITALIZATION. IT WAS EXPLAINED THAT THE PATIENT¿S REPORT OF CLOUDY BAGS ONLY REFERRED TO THEIR DRAIN BAGS AFTER PD TREATMENTS (INDICATING INFECTION) AND NOT OUT-OF-BOX DELFLEX SOLUTION BAGS. LABORATORY TESTING CONDUCTED IN THE HOSPITAL WAS NOT COMPLETED DUE TO THE SHORT TIME THE PATIENT WAS HOSPITALIZED AT THE TIME OF FOLLOW-UP. THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE DURING CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) THERAPY ON THE LIBERTY SELECT CYCLER AT HOME. THE PATIENT WAS PRESCRIBED ANTIBIOTICS WHILE HOSPITALIZED TO ADDRESS THE INFECTION, BUT THE TYPES, ROUTES AND DOSAGES WERE NOT REPORTED. IT WAS BELIEVED THE PATIENT WAS ABLE TO UNDERGO CCPD THERAPY ON A HOSPITAL PROVIDED CYCLER (UNKNOWN BRAND AND MODEL) FOR THE DURATION OF THE ADMISSION. THE PATIENT IS RECOVERING FROM THIS EVENT WHILE AWAITING DISCHARGE TO HOME. IT WAS CONFIRMED THE PATIENT¿S PERITONITIS AND ASSOCIATED HOSPITALIZATION WERE NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE PATIENT PLANS TO CONTINUE CCPD THERAPY ON THE SAME LIBERTY SELECT CYCLER AT HOME UPON DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294152 FMC CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER