BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1982880 · Received February 9, 2011

    Report

    Report Number
    1423500-2011-01703
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 17, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS AND BLOOD CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD1 AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT CONTACTED BAXTER (B)(4) REGARDING A LEAKING DRAIN BAG. AT THE TIME OF THE CALL, THE PATIENT STATED THAT PRIOR TO THE ISSUE OF THE DRAIN BAG LEAKING ON AN UNREPORTED DATE HE EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND "MILKY EFFLUENT DRAIN." THE NURSE STATED THAT THE CAUSE OF THE PERITONITIS WAS DUE TO AN "EXCHANGE DONE IN A DIFFERENT LOCATION ON VISIT, BATHROOM." ON THE SAME DAY, THE PATIENT BEGAN REMEDIAL THERAPY WITH ANCEF (2G LOADING, THEN 1G, DAILY, IP) AND GENTAMYCIN (120MG LOADING, THEN 40MG, DAILY, IP) FOR THE BACTERIAL PERITONITIS. ON (B)(6) 2011, THE PATIENT ENDED REMEDIAL THERAPY WITH ANCEF AND GENTAMYCIN AND THE BACTERIAL PERITONITIS RECOVERED. IT WAS NOT REPORTED WHETHER THE EVENT OF BLOOD CULTURE POSITIVE FOR (B)(6) RESOLVED. DIANEAL AND EXTRANEAL VIAFLEX THERAPIES WERE ONGOING. THE NURSE STATED THAT THE BACTERIAL PERITONITIS WAS NOT RELATED TO THE DIANEAL PD AND EXTRANEAL VIAFLEX THERAPIES AND DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF BLOOD CULTURE POSITIVE FOR (B)(6).

    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 55 YR Required Intervention DIANEAL PD1| EXTRANEAL VIAFLEX