BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 6816336 · Received August 24, 2017

    Report

    Report Number
    8030665-2017-00604
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 28, 2017
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100750
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THERE IS NO DOCUMENTATION THAT SHOWS A CAUSAL RELATIONSHIP BETWEEN THE EVENT OF PERITONITIS AND SUBSEQUENT HOSPITALIZATION RESULTING IN THE REMOVAL OF THE PD CATHETER AND THE LIBERTY CYCLER. ADDITIONALLY, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION AND THE ADVERSE EVENT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER OVER THE PAST 3 MONTHS. EHE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INFORMATION IN THE COMPLAINT FILE WAS REVIEWED BY A POST MARKET SURVEILLANCE CLINICIAN. ON 08/03/2017 IT WAS REPORTED BY A PERITONEAL DIALYSIS (PD) NURSE THAT THE PD PATIENT WITH END STAGE RENAL DISEASE (ESRD) PATIENT UTILIZING CONTINUOUS CYCLIC PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY WAS HOSPITALIZED FOR PERITONITIS. DURING THE HOSPITALIZATION THE RRT MODALITY WAS CHANGED TO HEMODIALYSIS (HD). DURING A FOLLOW-UP CALL ON (B)(6) 2017 TO THE PD NURSE IT WAS LEARNED THE PATIENT HAD BEEN HOSPITALIZED (DETAILS OF HOSPITALIZATION UNKNOWN) FROM (B)(6) 2017 TO (B)(6) 2017 FOR PERITONITIS (PD AFFLUENT POSITIVE FOR GRAM NEGATIVE RODS) AND WAS TREATED WITH THE ANTIBIOTIC GENTAMYCIN (ROUTE, DOSE, DURATION UNKNOWN). ON (B)(6) 2017 DURING THE HOSPITALIZATION THE PATIENTS¿ PD CATHETER WAS REMOVED AND THE PATIENT TRANSITIONED TO HD WITH A PLAN TO POTENTIALLY RETURN TO PD THERAPY IN 6-8 WEEKS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S CLINIC REGISTERED NURSE (RN) STATED THE PD PATIENT HAD BEEN HOSPITALIZED FROM (B)(6) 2017 DUE TO PERITONITIS AND AS OF (B)(6) 2017 WAS CURRENTLY RECEIVING HEMODIALYSIS THERAPY AS OF (B)(6) 2017 AND OFF CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY. PR THE PATIENT'S REPORT IT WAS FOUND THAT THE PD EFFLUENT HAD GRAM NEGATIVE RODS (GNR). WHILE IN THE HOSPITAL PATIENT'S PD CATHETER WAS REMOVED ON (B)(6) 2017. THE PATIENT WAS RELEASED, AND SHE WAS CURRENTLY RECOVERING AT HOME. MEDICAL RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598301 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 30 YR Hospitalization| R LIBERTY CYCLER| PD SOLUTION