BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3943466 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23188
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD896696 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. 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 ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERED OR WAS RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422247 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION GD896696

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization DIANEAL, HOMECHOICE