BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMC CASSETTE

    MDR report key: 9070401 · Received September 16, 2019

    Report

    Report Number
    8030665-2019-01470
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    August 30, 2019
    Report Date
    October 8, 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
    CA, 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

    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, FMC CASSETTE AND THE ADVERSE EVENT OF PERITONITIS WHICH WARRANTED ANTIBIOTIC THERAPY. PER THE PDRN, THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION, AFTER THE PATIENT FAILED TO PERFORM PROPER HAND HYGIENE AFTER USING THE RESTROOM. ENTEROCOCCUS FAECALIS IS PART OF HUMANS¿ NORMAL INTESTINAL FLORA (MEDSCAPE (2017). ENTEROCOCCAL INFECTIONS. HTTP://MISC.MEDSCAPE.COM/PI/ANDROID/MEDSCAPEAPP/HTML/A216993-BUSINESS.HTML). BASED ON THE INFORMATION AVAILABLE, THE LIBERTY CYCLER AND FMC CASSETTE CAN BE DISASSOCIATED FROM THE EVENT, AS THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A LIBERTY CYCLER AND/OR FMC CASSETTE PRODUCT DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THE SERIOUS ADVERSE EVENT. FURTHERMORE, THE PATIENT CONTINUES TO UTILIZE THE SAME LIBERTY CYCLER WITHOUT ANY REPORTED ISSUES OR ALLEGATIONS OF MACHINE MALFUNCTION OR DEFICIENCY. IT IS WELL ESTABLISHED THOSE INDIVIDUALS UNDERGOING PD THERAPY ARE AT HIGH RISK FOR INFECTIONS OF THE PERITONEUM (AKOH, J. A. (2012, AUGUST 6). PERITONEAL DIALYSIS ASSOCIATED INFECTIONS: AN UPDATE ON DIAGNOSIS AND MANAGEMENT. WORLD JOURNAL OF NEPHROLOGY, PP. 106-122). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE NEED FOR A CLINICAL INVESTIGATION WILL BE RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PDRN STATED PERITONEAL EFFLUENT FLUID CULTURES WERE COLLECTED ON (B)(6) 2019, AFTER THE PATIENT DETECTED FIBRIN IN HER PD EFFLUENT FLUID. THE CULTURES RETURNED POSITIVE FOR GRAM-POSITIVE ENTEROCOCCUS FAECALIS, AND A CELL COUNT REVEALED AN ELEVATED WBC COUNT OF 3875 U/L. THE PATIENT WAS TREATED AS AN OUTPATIENT AND PRESCRIBED INTRAPERITONEAL (IP) VANCOMYCIN 1 GRAM ONCE EVERY 5 DAYS. THE PDRN STATED THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION, AFTER IMPROPERLY PERFORMING HAND HYGIENE AFTER USING THE RESTROOM. THE PDRN STATED THE EVENTS WERE UNRELATED TO THE UTILIZATION OF THE LIBERTY SELECT CYCLER, LIBERTY CYCLER SET OR ANY FRESENIUS DEVICE(S), DRUG(S) OR PRODUCT(S). THE PATIENT IS RECOVERING FROM THE EVENT. ADDITIONAL INFORMATION AND PATIENT DEMOGRAPHICS WERE REQUESTED, HOWEVER THE REQUEST WAS DECLINED. NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865983 FMC CASSETTE 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| LIBERTY SELECT CYCLER