BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3120589 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12921
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER REVIEW OF THE BATCH RECORDS FOR POTENTIALLY ASSOCIATED LOT GD893560. NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS ON THE SAME DAY. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH CEFEPIME AND VANCOMYCIN FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THIS IS REPORT 2 OF 3, FOR THE MINICAP INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222000 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R HOMECHOICE, DIANEAL PD4 AMBUFLEX