BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3063699 · Received April 12, 2013

    Report

    Report Number
    8030665-2013-00201
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    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. UPON REMOVING THE TUBING SET FROM THE CYCLER FOLLOWING TREATMENT, FLUID LEAKED OUT OF THE CASSETTE COMPARTMENT. THE ORIGIN OF THE LEAK COULD NOT BE IDENTIFIED. PT DID NOT HAVE ANY ADVERSE EFFECTS FROM THE CASSETTE LEAK AND PT WAS NOT ADMINISTERED ANTIBIOTICS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157431 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MFG 13AR08890

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER