BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2843027 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05799
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS INCIDENT. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12G10158 AND H12H08085. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM THE NURSE: ON (B)(6) 2012, THE PD CATHETER WAS REMOVED, PD THERAPY WAS STOPPED AND HEMODIALYSIS THERAPY WAS INITIATED. THE NURSE CONFIRMED THE EVENT OF PERITONITIS AND HOSPITALIZATION DATE AS PREVIOUSLY REPORTED. THE CAUSE OF THE PERITONITIS WAS AN EXIT SITE INFECTION (ONSET DATE NOT REPORTED). THE NURSE THOUGHT THAT THE PATIENT WAS TREATED WITH GENTAMICIN AND FORTAZ IP FOR THE PERITONITIS. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT WAS DISCHARGED. THE OUTCOME OF THE EXIT SITE INFECTION WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS AN EXIT SITE INFECTION DUE TO A NON-BAXTER CATHETER DEVICE. THEREFORE, THIS EVENT IS NO LONGER CONSIDERED RELATED TO BAXTER PRODUCTS AND NO FURTHER INVESTIGATION WILL BE PERFORMED. THIS MEDWATCH IS NOW CONSIDERED A DUPLICATE TO MASTER MEDWATCH REPORT #1416980-2012-05798.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER IN THE USA. THIS REPORT IS OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FORM THIS PERITONITIS EVENT.

    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 44 YR Hospitalization DIANEAL PD4 AMBUFLEX