BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3873532 · Received June 14, 2014

    Report

    Report Number
    1416980-2014-19064
    Event Type
    Injury
    Date Received
    June 14, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD895797 AND GD895763 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. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    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 PRESUMED TO BE DUE TO AIRBORNE PARTICLES FROM AN OPEN WINDOW DURING PD THERAPY; HOWEVER, THIS WAS NOT MEDICALLY CONFIRMED. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS. PD THERAPY WAS REPORTED TO BE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351811 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE| CASSETTE| DIANEAL PD4 AMBUFLEX| TRANSFER SET| FLEXICAP