BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2132770 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07767
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW FOR THE POTENTIALLY ASSOCIATED LOT NUMBER (H11A19047) REVEALED NO DEVIATIONS DURING THE MANUFACTURE OF THESE DEVICES. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE REPORTER STATED THAT ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS THAT RESULTED IN HOSPITALIZATION ON (B)(6) 2011. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT PROVIDED FOR THE EVENT WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. ON AN UNREPORTED DATE, DIANEAL PD4 AMBUFLEX THERAPY WAS WITHDRAWN. THE CONSUMER STATED THAT THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. THE NURSE DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    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 65 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE