BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2000535 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02410
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 2, 2011
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE AN EVALUATION WAS NOT PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THE PRODUCT CODE AND LOT NUMBER WERE NOT PROVIDED; THEREFORE, A 510K NUMBER CANNOT BE PROVIDED AND A BATCH REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A PHYSICIAN FROM (B)(6) OF STERILE PERITONITIS IN A FEMALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2011, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON THE SAME DAY, EXTRANEAL VIAFLEX THERAPY WAS WITHDRAWN AND THE PATIENT BEGAN TREATMENT WITH PHYSIONEAL IP FOR APD. ON THE SAME DAY, THE PATIENT BEGAN REMEDIAL THERAPY WITH KEFZOL (1G/D, DAILY, IP) AND FORTAM (1G/D, DAILY, IP). ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED AND DISCHARGED ON (B)(6) 2011. ON AN UNREPORTED DATE IN 2011, THE PHYSICIAN REPORTED THAT THE PATIENT SPECIFICALLY IMPROVED WITH THE DISCONTINUATION OF EXTRANEAL VIAFLEX THERAPY. ON (B)(6) 2011, THE PATIENT WAS SCHEDULED TO END REMEDIAL THERAPIES WITH KEFZOL AND FORTAM. THE EVENT OF STERILE PERITONITIS WAS REPORTED AS ONGOING AND IMPROVING. THE PHYSICIAN REPORTED THE EVENT OF STERILE PERITONITIS WAS POSSIBLY RELATED TO THE EXTRANEAL VIAFLEX, AND NOT RELATED TO PHYSIONEAL THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R HOMECHOICE CYCLER| PHYSIONEAL| EXTRA.7.5.VIAFLEX