BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2111432 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06966
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. ON UNREPORTED DATES, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THAT ON AN UNREPORTED DATE IN 2011, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. TREATMENT INFORMATION INCLUDED ANTIBIOTICS (DRUG, DOSE AND START/STOP DATES NOT REPORTED). THE PATIENT WAS NOT HOSPITALIZED AND WAS RECOVERING FROM THE EVENTS. DIANEAL THERAPY WAS ONGOING. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR STREPTOCOCCUS WAS NOT RELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION 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 52 YR Required Intervention DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG