BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2143407 · Received June 29, 2011

    Report

    Report Number
    1423500-2011-08487
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE.

    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 GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). IN 2011, THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR AN UNREPORTED INDICATION. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN, 1 GM, ONCE DAILY, IP AND AMIKACIN, 500 MG, ONCE DAILY, IP. ON (B)(6) 2011, REMEDIAL THERAPY WITH VANCOMYCIN AND AMIKACIN WAS DISCONTINUED AND THE EVENT OF PERITONITIS HAD RESOLVED. THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. DIANEAL THERAPY CONTINUED WITH DOSE UNSPECIFIED. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO THE SUSPECT PRODUCT. A CAUSALITY ASSESSMENT WAS NOT PROVIDED FOR THE BREAK IN ASEPTIC TECHNIQUE.

    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 58 YR Required Intervention DIANEAL PD2 ULTRABAG