BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3268953 · Received August 7, 2013

    Report

    Report Number
    1416980-2013-21045
    Event Type
    Malfunction
    Date Received
    August 7, 2013
    Report Date
    July 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE THAT WAS USED AS WELL AS (B)(4) COMPANION DEVICES ARE REPORTED TO BE AVAILABLE BUT HAVE NOT YET BEEN RECEIVED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR LOT NUMBER H13C07061 WAS PERFORMED 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. SHOULD THE DEVICES BE RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE USED WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN NUMBER OF MINI CAP TRANSFER SETS HAD CONNECTION ISSUES WHEN CONNECTING NON-BAXTER BETA CAP ADAPTERS. WHEN THESE ADAPTERS WERE USED, THEY DID NOT FIT RIGHT AND DID NOT TIGHTEN PROPERLY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370504 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13C07061

    Patients

    Seq Age Sex Outcome Treatment
    1 TYCO/HEALTHCARE BETA CAP ADAPTERS