BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3944867 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23320
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    January 26, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896415 AND GD896845 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. AS THE SAMPLE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). 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 PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH AND UNSPECIFIED INTRAVENOUS (IV) ANTIBIOTIC (MEDICATION, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) AND AN UNSPECIFIED INTRAPERITONEAL (IP) ANTIBIOTIC (MEDICATION, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. EIGHT DAYS AFTER HOSPITALIZATION STARTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT WAS RECOVERED 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
    421905 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R HOMECHOICE, MINICAP TRANSFER SET, EXTRANEAL,| DIANEAL PD4 2.5% AND 4.25% AMBUFLEX,| HOMECHOICE AUTOMATED PD SET WITH CASSETTE