BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3020017 · Received March 25, 2013

    Report

    Report Number
    1416980-2013-07148
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED AND ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION. VISUAL INSPECTION PERFORMED WITH THE FOLLOWING ISSUES NOTED: BROKEN OCCLUDER FEET. LEAK TESTING PERFORMED WITH NO ISSUES NOTED. CLEAR PASSAGE TEST PERFORMED WITH NO ISSUES NOTED. CLAMP FUNCTION TEST PERFORMED WITH THE FOLLOWING ISSUES NOTED: BROKEN OCCLUDER FEET. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE SAMPLE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THERE WAS A LEAK THAT OCCURED AT THE TOP OF THE TRANSFER SET ALTHOUGH THE CLAMP WAS CLOSED. THE PATIENT PUT ANOTHER CLAMP ON THE SET AND PUT ON THE MINICAP. THEN THE PATIENT CONTACTED THE HOSPITAL FOR AN EXCHANGE OF THE SET. THE SET WAS INITIALLY COUPLED TO THE PATIENT TWO MONTHS PRIOR. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122866 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12B20018

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE