BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 4551398 · Received February 25, 2015

    Report

    Report Number
    8030665-2015-00101
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Date of Event
    January 29, 2015
    Report Date
    January 29, 2015
    Manufacturer
    REYNOSA MGR
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMNPLETION IF THE PLANT¿S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT REPORTED FINDING A FLUID LEAK FOLLOWING HIS DISCONTINUED TREATMENT. AFTER RECEIVING A CYCLER ALARM, HE OPENED THE CASSETTE DOOR AND DISCOVERED FLUID LEAKING FROM THE CASSETTE DOOR. THE SAMPLE SET WAS NOT RETAINED FOR EVAL. DURING FOLLOW UP THE PT¿S PD NURSE REPORTED THAT PT WAS FINE. HE DID NOT HAVE SIGNS OF INFECTION. HE WAS NOT PRESCRIBED PROPHYLACTIC ANTIBIOTICS. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132617 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MGR

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR LIBERTY CYCLER,| PD SOLUTION