BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3130717 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13453
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 GD894162, GD894006 AND GD893743 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). THERAPY WAS ONGOING. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT FOR THE EVENTS WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232619 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization HOMECHOICE, DIANEAL PD4 ULTRABAG