BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE PATIENT CONN

    MDR report key: 3002393 · Received March 8, 2013

    Report

    Report Number
    8030665-2013-00139
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 9, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, HOWEVER A COMPANION SAMPLE FROM THE SAME LOT WAS RETURNED FROM THE DISTRIBUTION CENTER FOR INVESTIGATION AND NO DEFECTS WERE NOTED. IN ADDITION, 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.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT THE PT LINE BECAME DISCONNECTED DURING TREATMENT. THE PT WAS ASLEEP AND UPON WAKING UP, SAW THAT THE CATHETER WAS EXPOSED. PT HAD NO ILL EFFECTS. THE ACTUAL SAMPLE IS NOT AVAILABLE. THE INITIAL LOT NUMBER AT THE TIME OF THE REPORT WAS NOT KNOWN. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER ONE MONTH PRIOR TO THE DATE OF REPORTED PRODUCT ISSUE. COMPANION SAMPLES OF THE SAME LOT NUMBER ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99909 LIBERTY CYCLER SET, SINGLE PATIENT CONN LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MANUFACTURING 12NR08035

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR LIBERTY DIALYSIS CYCLER