BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2882574 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07883
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDI
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. LEAK TESTING WAS PERFORMED WITH NO ISSUES NOTED. A CLEAR PASSAGE TEST AND CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS DIMENSIONALLY INSPECTED AND THE INSIDE DIAMETER OF THE PATIENT CONNECTOR WAS NOT WITHIN SPECIFICATION. THE TRANSFER SET PATIENT CONNECTOR WOULD NOT CONNECT PROPERLY TO THE TITANIUM ADAPTER IF THE PATIENT CONNECTOR DIMENSIONS ARE NOT WITHIN SPECIFICATION. THE SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM AND THE ROOT CAUSE WAS IDENTIFIED TO BE MANUFACTURING RELATED. CORRECTIVE ACTIONS WERE PERFORMED IN (B)(4) 2013 AT THE MOUNTAIN HOME BAXTER MANUFACTURING FACILITY TO ENSURE THAT THE INSIDE DIAMETER OF THE TRANSFER SET PATIENT CONNECTOR WOULD BE MOLDED TO THE PROPER SPECIFICATION.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE CONTACTED BAXTER (B)(4) REGARDING A CONNECTION ISSUE WITH A MINICAP TRANSFER SET. THE REPRESENTATIVE STATED THAT THE TRANSFER SET WAS NOT CONNECTED TO THE TITANIUM ADAPTOR TIGHTLY. THERE WAS PATIENT INVOLVEMENT; PATIENT INJURY OR MEDICAL INTERVENTION WAS NOT REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MOUNTAIN HOME H12D18059

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSFER SET