BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3910194 · Received July 2, 2014

    Report

    Report Number
    1416980-2014-21268
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED PERITONITIS ON AN UNKNOWN DATE IN (B)(6) 2014. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS COMPLAINTS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED INDICATION AND LATER ACQUIRED PERITONITIS. IT WAS NOT REPORTED IF THE PERITONITIS EVENT PROLONGED THE HOSPITALIZATION. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR THE EVENT. AT TIME OF THIS REPORT THE PATIENT WAS REPORTED TO BE RECOVERED FROM THE PERITONITIS BUT REMAINED HOSPITALIZED FOR OTHER UNRELATED INDICATIONS. PD THERAPY WAS REPORTED TO BE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 2 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387020 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTRANEAL VIAFLEX| DIANEAL PD4 2.5% ULTRABAG| HOMECHOICE| TRANSFER SET