BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3251255 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19985
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD894188 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 5 FOR THIS EVENT. THIS IS A REPORT OF A PATIENT WHO EXPERIENCED PERITONITIS. TWO DAYS LATER, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE PATIENT'S CATHETER WAS REMOVED AND THE PATIENT WAS MOVED TO HEMODIALYSIS. ON AN UNKNOWN DATE, THE TREATMENT FOR THE EVENT INCLUDED UNSPECIFIED ANTIBIOTIC AND ANTIFUNGAL MEDICATIONS. TWO WEEKS AFTER THE HOSPITALIZATION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352810 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R HOMECHOICE AUTOMATED PD SET WITH CASSETTE,| HOMECHOICE, DIANEAL PD4 AMBUFLEX| MINICAP TRANSFER SET, FLEXICAP, EXTENSION SET,