BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2220924 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11135
    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
    IN
    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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE FOLLOWING INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE CONSUMER; ON AN UNREPORTED DATE IN 2011, THE EVENT OF PERITONITIS RESOLVED AND REMEDIAL TREATMENTS WITH VANCOMYCIN AND CEFTAZIDIME WERE DISCONTINUED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, NOT REQUIRING HOSPITALIZATION. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN 1 G/L IP LOADING DOSE, VANCOMYCIN 1 G/L IP, WITH MAINTENANCE DOSE TO BE REPEATED ON THE 8TH DAY, CEFTAZIDIME 500 MG/L IP LOADING DOSE WITH CEFTAZIDIME 500 MG/L MAINTENANCE DOSE TO BE REPEATED ON THE 8TH DAY. THE CAUSE OF PERITONITIS WAS REPORTED AS UNKNOWN AND THE OUTCOME WAS REPORTED AS RESOLVING. DIANEAL THERAPY CONTINUED. CAUSALITY ASSESSMENT FOR THE EVENT OF PERITONITIS TO DIANEAL WAS NOT REPORTED.

    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 62 YR Required Intervention DIANEAL PD2 ULTRABAG