BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2760968 · Received September 26, 2012

    Report

    Report Number
    1416980-2012-00786
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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 NUMBERS H12A02018, H12C30049, H12D30047 AND H12G09010 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A NURSE IN (B)(6) OF SHORTNESS OF BREATH AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, APPROXIMATELY THE WEEK OF (B)(6) 2012, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND CLOUDY PD EFFLUENT. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR SHORTNESS OF BREATH. THE PATIENT RECEIVED UNSPECIFIED ANTIBIOTICS FOR THE EVENT. ON AN UNREPORTED DATE, DURING THE HOSPITALIZATION THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF PERITONITIS AND SHORTNESS OF BREATH WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY.

    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 65 YR Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX| HOMECHOICE