BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2122879 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07580
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H11B13071 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF HYPOTENSION AND STAPH EPI PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG, AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED HYPOTENSION. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE HYPOTENSION. ON AN UNREPORTED DATE WHILE HOSPITALIZED, THE PATIENT EXPERIENCED STAPH EPI PERITONITIS. TREATMENT DURING HOSPITALIZATION WAS NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT RECOVERED FROM THE EVENT OF HYPOTENSION. THE PATIENT WAS RECOVERING FROM THE EVENT OF STAPH EPI PERITONITIS. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. THE NURSE REPORTED THAT THE HYPOTENSION AND STAPH EPI PERITONITIS WERE UNRELATED TO DIANEAL AND EXTRANEAL THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG| HOMECHOICE| EXTRANEAL VIAFLEX