BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3803022 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15024
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13G18044, H13I06037, H13K01019 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE IN (B)(6) 2014, THE PATIENT EXPERIENCED PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE IN THE SAME MONTH AS ONSET, THE PT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. ON AN UNREPORTED DATE WITHIN SAME MONTH AS BEING ADMITTED, THE PT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PT WAS RECOVERING, AND DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 5 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281541 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization FLEXICAP| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| CAPD DISCONNECT Y SET| DIANEAL PD4, 2.5% AMBUFLEX| MINICAP