BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3945012 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23366
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE MINICAP TRANSFER SET WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBERS WILL BE PERFORMED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE PERTAINING TO THE REPORTED EVENT, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13K14046 AND H14B18010 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED BUT WAS NOT HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPY WAS ONGOING. THE PATIENT WAS TREATED WITH AMOXICILLIN (DOSE AND FREQUENCY NOT REPORTED). AFTER BEGINNING TREATMENT, THE PATIENT EXPERIENCED DIARRHEA. TREATMENT WAS THEN SWITCHED TO AN UNKNOWN ANTIBIOTIC (DOSE AND FREQUENCY NOT REPORTED) FOR 20 DAYS. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421714 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention HOMECHOICE, MINICAP| DIANEAL PD4 ULTRABAG| EXTRANEAL VIAFLEX