BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2122886 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07585
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF BACTERIAL PERITONITIS IN PATIENT COINCIDENT WITH DIANEAL (UNKNOWN) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS,MANIFESTED BY CLOUDY EFFLUENT AND ABDOMEN PAIN, AND WAS HOSPITALIZED FROM (B)(6) 2011 TO (B)(6) 2011. TREATMENT INCLUDED UNSPECIFIED ANTIBIOTICS. THE CAUSE OF THE BACTERIAL PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE EVENT RESOLVED. DIANEAL THERAPY CONTINUED. THE NURSE CONSIDERED THE EVENT OF BACTERIAL PERITONITIS TO BE UNRELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL