BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2220972 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11140
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 2, 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). 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 3 OF 6 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBER: H11E05047 WITH NO DEFECTS NOTED DURING THE MANUFACTURE OF THAT LOT RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH RENQ-CAPA-(B)(4) AND NCR (B)(4).

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS CONSUMER REPORT FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT INFORMATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. IT WAS NOT REPORTED WHETHER DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT PROVIDED. 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 47 YR Hospitalization DIANEAL PD4 AMBUFLEX