BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3844021 · Received June 2, 2014

    Report

    Report Number
    1416980-2014-17704
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD895953 AND GD896209 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 AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS NOT REPORTED. ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE EVENT. TREATMENT AND OUTCOME WERE UNKNOWN. SEVEN DAYS AFTER ADMISSION TO THE HOSPITAL, THE PT WAS DISCHARGED. THE PD THERAPY IS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321513 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization HOMECHOICE| MINICAP TRANSFER SET| DIANEAL 2.5% AND 4.25% ULTRABAG