BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2220822 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11120
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    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 USE ERROR- POOR ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE IN THE (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT, COINCIDENT WITH DIANEAL PD2 UNKNOWN THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE IN 2011, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY POOR DRAIN AND WAS HOSPITALIZED ON THE SAME DATE. THE CAUSE OF THE PERITONITIS WAS BREAK IN ASEPTIC TECHNIQUE. AT THAT TIME, THE PATIENT STARTED TREATMENT WITH VANCOMYCIN. THE PATIENT REMAINED HOSPITALIZED. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING. THE PERITONITIS WAS ONGOING. IT WAS NOT REPORTED IF THE BREAK IN ASEPTIC TECHNIQUE HAD RESOLVED. THE NURSE BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. A CAUSALITY STATEMENT FOR THE BREAK IN ASEPTIC TECHNIQUE WAS NOT PROVIDED.

    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 63 YR Hospitalization| R DIANEAL PD2 UNKNOWN