BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 3140310 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13919
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBERS GD894022 AND GD893875 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 FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THREE DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241336 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization DIANEAL PD4 AMBUFLEX