BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2173659 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09348
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE AND PHYSICIAN FROM (B)(4) OF BACTERIAL PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN, EXTRANEAL VIAFLEX, PHYSIONEAL UNSPECIFIED PRODUCT AND PHYSIONEAL 35 UNKNOWN BAG THERAPIES FOR PERITONEAL DIALYSIS (PD). MULTIPLE REPORTS WERE RECEIVED FROM THE SAME REPORTER. THIS IS REPORT 2 OF 4. FOLLOW-UP INFORMATION REVEALED THAT ON (B)(6) 2011 THE PATIENT EXPERIENCED BACTERIAL PERITONITIS, REQUIRING HOSPITALIZATION (DATES NOT REPORTED). BREVIBACTERIUM WAS INVOLVED. DUE TO THE 4 EVENTS OF BACTERIAL PERITONITIS, THE PD CATHETER WAS REMOVED ON AN UNREPORTED DATE. OUTCOME WAS NOT REPORTED FOR ANY OF THE EVENTS OF BACTERIAL PERITONITIS. ON AN UNREPORTED DATE, DIANEAL WAS WITHDRAWN, EXTRANEAL AND PHYSIONEAL UNSPECIFIED PRODUCT WERE TEMPORARILY WITHDRAWN AND ACTION TAKEN WITH PHYSIONEAL 35 UNKNOWN BAG WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PD CATHETER WAS PUT BACK IN PLACE. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY.

    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 38 YR Hospitalization| R DIANEAL,EXTRANEAL AND PHYSIONEAL, PHYSIONEAL 35| BURINEX (BUMETANIDE), ZYLORIC (ALLOPURINOL)| FORLAX (MACROGOL), ALPHA LEO (ALFACALCIDOL)| CALCIUM ACETATE AND SODIUM BICARBONATE| DIANEAL,EXTRANEAL AND PHYSIONEAL, PHYSIONEAL 35