BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3133057 · Received May 24, 2013

    Report

    Report Number
    8030665-2013-00324
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS HAVE BEEN REQUESTED AND HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. AT THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE CLINICAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. 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. THIS MEDWATCH REPORT IS ASSOCIATED WITH MDR # 2937457-2013-00068.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PT FOUND FLUID IN THE CYCLER WEN HE OPENED THE CASSETTE DOOR AFTER TREATMENT. PT COULD NOT IDENTIFY WHERE THE LEAK OCCURRED. PD NURSE STATED THAT PT WENT TO THE CLINIC ON (B)(6) 2013 AND HAD ACQUIRED PERITONITIS FROM THE INCIDENT. ANTIBIOTICS WERE ADMINISTERED AND THE PERITONITIS WAS RESOLVED. PT WAS FINE. NURSE ALSO STATED THAT PT WAS ADMITTED IN THE HOSPITAL ON (B)(6) 2013 TO HAVE THE CATHETER REMOVED DUE TO RECURRENT PERITONITIS. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232790 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 13BR08828

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R LIBERTY DIALYSIS CYCLER