BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2820963 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04169
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    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 4 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS H11C03013, H11H19059, H12A02018, AND H12B06041. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    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 OF CONSTIPATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). THE ACTION TAKEN WITH DIANEAL THERAPIES WAS NOT REPORTED. DURING A CALL WITH BAXTER CUSTOMER SERVICES (BCS), THE FOLLOWING INFORMATION WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED CONSTIPATION. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS DUE TO CONSTIPATION AND WAS HOSPITALIZED FOR THE EVENT. TREATMENT RENDERED WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG| HOMECHOICE