BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3250815 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19934
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    April 22, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBER GD893891 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM THE STANDARD PROCEDURE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS AND A CATHETER INFECTION COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE REPORTED EVENT. THE TREATMENT INCLUDED VANCOMYCIN (1 GM, 3 TIMES DAILY FOR 5 DAYS, INTRAPERITONEALLY (IP)) AND GENTAMYCIN (40 MG, 3 TIMES DAILY IP). THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353817 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention HOMECHOICE, APD SET W/CASSETTE| DIANEAL PD4 1.5% AND 2.5%, EXTRANEAL