BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

    MDR report key: 5224929 · Received November 10, 2015

    Report

    Report Number
    8030665-2015-00513
    Event Type
    Injury
    Date Received
    November 10, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 12, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKC
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. DEVICE REVIEW: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE MANUFACTURER WITH THE LOT NUMBER OF THE PRODUCT USED IN THE REPORTED EVENT. AS NO LOT NUMBER WAS PROVIDED BY THE COMPLAINANT, A RECORD REVIEW WAS PERFORMED ON EACH OF THE LOT NUMBERS SHIPPED TO THE COMPLAINANT IN THE THREE MONTHS LEADING UP TO THE REPORTED EVENT. THE RECORD REVIEW FOUND 2 LOT NUMBERS SHIPPED TO THE CUSTOMER DURING THAT TIME PERIOD. THE BATCH PRODUCTION RECORDS FOR THESE LOTS WERE REVIEWED. THE BATCH RECORDS CONFIRMED THAT RELEASED PRODUCT MET SPECIFICATIONS; AND DOCUMENTED MANUFACTURING PROCESS CONTROLS WERE WITHIN SPECIFICATIONS. PER THE DOCUMENTED PRODUCT INVESTIGATION, THERE WAS NO INDICATION THAT THE FRESENIUS PRODUCT CAUSED, CONTRIBUTED TO OR WAS A FACTOR IN THE REPORTED EVENT.

    Description of Event or Problem · 1

    ANOTHER MANUFACTURER REPORTED A PERITONEAL DIALYSIS (PD) PATIENT "KEPT GETTING PERITONITIS" WHILE USING FRESENIUS PRODUCTS. IT WAS NOTED THE PATIENT SWITCHED TO ANOTHER MANUFACTURE'S PRODUCTS AND HAVE NOT HAD ANY PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745917 LIBERTY CYCLER SET, SINGLE CONN./EXT.DL FKC FRESENIUS MEDICAL CARE NORTH AMERICA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other