BEUDAMED
    FDA Adverse Event Summary report: N

    LIBERTY CYCLER SET, SINGLE PA

    MDR report key: 3180014 · Received June 13, 2013

    Report

    Report Number
    8030665-2013-00374
    Date Received
    June 13, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 19, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL; HOWEVER, A COMPANION SAMPLE FROM THE SAME LOT WAS RETURNED FOR INVESTIGATION AND NO DEFECTS WERE NOTED. IN ADDITION, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. BASED ON THE PT'S REPORT OF PERITONITIS, IT IS UNK IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE PT IS UNSURE IF THE DIAGNOSIS WAS RELATED TO THE TREATMENT. FOLLOW-UP WITH THE PT'S PDRN STATED SHE WAS ALSO UNSURE IF THE EVENTS WERE RELATED; HOWEVER, SHE WAS NOT AWARE OF THE CASSETTE BEING REPORTED TO LEAK. WE ARE FILING THIS MDR AS A SERIOUS INJURY AS IV ANTIBIOTICS WERE ADMINISTERED TO THE PT AND THERE IS NO INDICATION OF THE CAUSE OF THE PERITONITIS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT REPORTED SHE RECEIVED AN "AIR IN CASSETTE" ALARM AND SHORTLY LATER WAS DIAGNOSED WITH PERITONITIS. DURING A FOLLOW-UP CALL WITH THE PT, SHE STATED SHE WAS DIAGNOSED WITH PERITONITIS FOLLOWING THE EVENT. THE PT DOES NOT KNOW THE CAUSE. SHE WAS PLACED ON IV ANTIBIOTICS AND RECEIVED A SHOT OF IRON. THE PERITONITIS HAS SINCE RESOLVED AND THE PT IS DOING WELL. PT DISCARDED THE ACTUAL SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269358 LIBERTY CYCLER SET, SINGLE PA FKX FRESENIUS MEDICAL CARE NORTH AMERICA 13AR08815

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LIBERTY CYCLER