BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3944861 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23321
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    January 26, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13J16050, H13K04070, H13K01019, H13K14046, H14A07064, H14A09029, H14A22089, H14B18010, H14B28035, H14A15026, H14B19042, AND H14D01012 WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE AND LOT NUMBER OF THIS PRODUCT ARE UNKNOWN; HOWEVER, THE BRAND NAME AND 510K NUMBER OF THE POTENTIAL PRODUCT CODES AND LOTS RECEIVED BY THE CLINIC ARE THE SAME; THEREFORE THEY WERE PROVIDED.   THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH AND UNSPECIFIED INTRAVENOUS (IV) ANTIBIOTIC (MEDICATION, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) AND AN UNSPECIFIED INTRAPERITONEAL (IP) ANTIBIOTIC (MEDICATION, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. EIGHT DAYS AFTER HOSPITALIZATION STARTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422220 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R DIANEAL PD4 2.5% AND 4.25% AMBUFLEX,| HOMECHOICE, MINICAP, EXTRANEAL,| HOMECHOICE AUTOMATED PD SET WITH CASSETTE