BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3973336 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25061
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896415 AND GD896597 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. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FIVE DAYS PRIOR TO THE DIAGNOSIS OF PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED INTRAVENOUS (IV) ANTIBIOTICS (MEDICATION, DOSAGE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. IV ANTIBIOTIC THERAPY WAS REPORTED TO BE ONGOING. ON AN UNREPORTED DATE DURING HOSPITALIZATION, THE PATIENT'S PD CATHETER WAS REMOVED AND PD THERAPY WAS DISCONTINUED. ON AN UNREPORTED DATE DURING HOSPITALIZATION, THE PATIENT WAS STARTED ON HEMODIALYSIS. AFTER EIGHT DAYS OF HOSPITALIZATION, THE PATIENT WAS DISCHARGED. IT WAS REPORTED THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450869 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R DIANEAL 1.5% AND 2.5% PD4 ULTRABAG| DIANEAL 1.5% AND 2.5% PD4 SINGLEBAG| CASSETTE, HOMECHOICE, MINICAP TRANSFER SET