BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3130376 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13392
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER GD893891 AND GD894022. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS CMPLNT-001616856.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE PD THERAPY WAS DISCONTINUED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. THIS IS REPORT 1 OF 2 FOR THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231249 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization DIANEAL PD4 ULTRABAG AND EXTRANEAL VIAFLEX