BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3900553 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20700
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    June 2, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896316 AND GD896290 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION. THE DEVICE WAS NOT RETURNED, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN, DIARRHEA AND CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THIRTEEN DAYS AFTER ONSET, THE PT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT FOR THE PERITONITIS WITH ANCEF (1GM, FREQUENCY NOT REPORTED) IP (INTRAPERITONEALLY). TWO DAYS AFTER BEING ADMITTED, THE PT WAS DISCHARGED FROM THE HOSPITAL. TWENTY SEVEN DAYS AFTER DISCHARGE FROM THE HOSPITAL, THE PT DISCONTINUED THE ANCEF THERAPY. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PT WAS RECOVERING, AND DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378083 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DIANEAL PD4, 1.5% ULTRABAG| DIANEAL PD4, 2.5% ULTRABAG| MINICAP TRANSFER SET