BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3873213 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18983
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD896415 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY THE PATIENT¿S CATHETER LOOKING CLOUDY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH CEFAZOLIN (1GM DAILY FOR 2 WEEKS, ROUTE NOT REPORTED) AND CEFTAZADIME (1GM DAILY FOR 2 WEEKS, ROUTE NOT REPORTED). THE PATIENT RECOVERED FROM THE PERITONITIS. DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351354 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention HOMECHOICE AUTOMATED PD SET WITH CASSETTE,| HOMECHOICE, FLEXICAP, MINICAP TRANSFER SET| DIANEAL PD4 1.5% AND 2.5% AMBUFLEX,