BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER SET

    MDR report key: 2133349 · Received June 13, 2011

    Report

    Report Number
    8030665-2011-00026
    Event Type
    Death
    Date Received
    June 13, 2011
    Date of Event
    September 2, 2010
    Report Date
    June 13, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A REPORT HAS BEEN REC'D FROM THE FDA WHICH STATED THE FOLLOWING: THIS PT WAS A PERITONEAL DIALYSIS PT WHO DIED ON (B)(6) 2010, THE DIAGNOSIS AT THE TIME OF DEATH WAS SEPTIC SHOCK/MASSIVE INFECTION. HOWEVER, THE INFO PROVIDED DID NOT MENTION THE PRESENCE OR OCCURRENCE OF ANY SPECIFIC PRODUCT PROBLEM OR DEFECT. THIS MFR WAS NOT ABLE TO OBTAIN ANY ADD'L INFO. THEREFORE, SINCE INCONCLUSIVE FINDINGS REGARDING PRODUCT PERFORMANCE AND AN INABILITY TO PERFORM ADEQUATE PRODUCT COMPLAINT INVESTIGATION TO PROVIDE SUFFICIENT EVIDENCE THAT THE PRODUCT PERFORMED PER SPECIFICATION, THIS REPORT IS BEING FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET PERITONEAL DIALYSIS TREATMENT SET FKX REYNOSA MANUFACTURING NA 09HR08131

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death