BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1983373 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01719
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    March 1, 2010
    Report Date
    January 20, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REGULATORY REPORT OF ASEPTIC PERITONITIS IN A PATIENT FROM (B)(6) COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). THIS CASE WAS INTIALLY RECEIVED BY BAXTER (B)(4) FROM A PHYSICIAN. ON (B)(6) 2010, THE PATIENT EXPERIENCED ASEPTIC PERITONITIS AND WAS HOSPITALIZED. THERE WAS NO SIGN OF BACTERIAL INFECTION AND THE PATIENT RECEIVED TREATMENT WITH UNSPECIFIED ANTIBIOTICS. ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE ASEPTIC PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL. PD THERAPY CONTINUED. THE REPORTING PHYSICIAN BELIEVED THE EVENT OF ASEPTIC PERITONITIS WAS RELATED TO EXTRANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R ETALPHA| PHYSIONEAL| EXTRANEAL VIAFLEX| C6ARVEDILOL| ARANESP