BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 3002577 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06017
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: GD893578 AND GD893447. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT INITIALLY WAS HOSPITALIZED FOR GASTRITIS. ON AN UNKNOWN DATE, DURING HOSPITALIZATION, PERITONITIS WAS DIAGNOSED. THE CAUSE AND TREATMENT FOR THIS EVENT WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS RE-TRAINED ON A PROPER ASEPTIC TECHNIQUE. ON AN UNKNOWN DATE BY THE TIME OF HOSPITAL DISCHARGE, THE PATIENT RECOVERED FROM THE EVENTS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THREE DAYS LATER. THIS IS REPORT 1 OF 2 ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105166 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization DIANEAL PD4 ULTRABAG