BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3809915 · Received April 25, 2014

    Report

    Report Number
    8030665-2014-00327
    Event Type
    Death
    Date Received
    April 25, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 28, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L ATTEMPTS TO THE HOSP CONTACT HAVE BEEN MADE WITH NO ADD'L INFO PROVIDED. THIS MDR INCLUDES ALL EVENT INFO RECEIVED TO DATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW BY POST MARKET CLINICAL PHYSICIAN AND COMPLETION OF THE PT'S INVESTIGATION. A DEATH HAS BEEN ALLEGED AGAINST THE CYCLER MACHINE. DUE TO LACK OF INFO MDR'S WILL BE FILED FOR EACH CONCOMITANT DEVICE AS PART OF A SYSTEM LEVEL REVIEW.

    Description of Event or Problem · 1

    A HOSP CONTACT CALLED INTO CUSTOMER SERVICE REQUESTING TO KNOW WHAT TO DO WITH A CYCLER WHEN A PT EXPIRES. IT WAS NOTED THE STAFF NOTICED THE PT PASSING WHILE HE WAS IN DWELL 2, BUT DID NOT CALL TIME OF DEATH UNTIL HE WAS DISCONNECTED FROM TREATMENT. THE CONTACT DID NOT BELIEVE THE PT'S PASSING WAS RELATED TO HIS PERITONEAL DIALYSIS TREATMENT, BUT HE COULD NOT BE SURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250898 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX FRESENIUS MEDICAL CARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LIBERTY CYCLER| PD SOLUTION