BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 8905250 · Received August 19, 2019

    Report

    Report Number
    8030665-2019-01305
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 26, 2019
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100750
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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: A CLINICAL INVESTIGATION WAS PERFORMED. THERE IS A TEMPORAL RELATIONSHIP BETWEEN PD THERAPY ON THE LIBERTY SELECT CYCLER WITH CYCLER SET AND THE PATIENT EVENT OF ABDOMINAL PAIN AND SUBSEQUENT DIAGNOSIS OF PERITONITIS. THERE IS A POSSIBLE CAUSAL RELATIONSHIP BETWEEN THE PERITONITIS EVENT AND A CASSETTE LEAK THAT THE PATIENT EXPERIENCED DURING TREATMENT PRIOR TO THE DIAGNOSIS. THE CASSETTE WAS NOT RETAINED FOR EVALUATION. STREPTOCOCCUS ORALIS AND MITIS ARE PART OF THE NORMAL ORAL MUCOSA INDICATING THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE, POSSIBLY CAUSED BY THE CASSETTE LEAK. IT IS UNKNOWN IF THE PATIENT FOLLOWED PROPER ASEPTIC TECHNIQUE DURING SET-UP OF THE TREATMENT. THERE IS NO REPORTED ISSUE WITH THE LIBERTY SELECT CYCLER IN RELATION TO THE PERITONITIS EVENT. BASED ON THE AVAILABLE INFORMATION, THE CYCLER SET CANNOT BE EXCLUDED AS CAUSING THE PATIENT EVENT OF PERITONITIS. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    A NURSE FOR A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS. UPON FOLLOW UP, THE PERITONEAL DIALYSIS NURSE (PDRN) REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2019 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PD EFFLUENT CULTURE WAS POSITIVE FOR STREPTOCOCCUS MITIS AND STREPTOCOCCUS ORALIS WITH A WHITE CELL COUNT OF 17,450 (UNKNOWN UNITS). THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) VANCOMYCIN 1G AND IP CEFTAZIDIME 1G (FREQUENCY AND DURATION UNKNOWN). ADDITIONALLY, THE PATIENT WAS PRESCRIBED ORAL (PO) LEVAQUIN (DOSE, FREQUENCY AND DURATION UNKNOWN). THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT. THE PDRN THE CAUSE OF THE PERITONITIS WAS A CASSETTE LEAK. THE PATIENT CONTACT CONFIRMED THE LEAK OCCURRED AT THE END OF TREATMENT ON (B)(6) 2019 AFTER HAVING REPORTED A BALLOON VALVE LEAK ALARM EARLIER IN THE TREATMENT. THE PATIENT IS CURRENTLY RECOVERING AS THEY HAVE THEIR CELL COUNTS DRAWN. THE PATIENT HAS BEEN CONTINUING PD THERAPY THROUGH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702357 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 46 YR Required Intervention DELFLEX PD FLUID| LIBERTY SELECT CYCLER| DELFLEX PD FLUID| LIBERTY SELECT CYCLER