BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2903533 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00568
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 2, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE SAMPLE WAS RETURNED TO BAXTER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT FOR A REPORT OF A LEAK WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. A CLEAR PASSAGE TEST WAS PERFORMED WITH NO ISSUES NOTED. A CLAMP FUNCTION TEST WAS PERFORMED AND IT WAS NOTED THAT THE OCCLUDER FEET WERE BROKEN. A FURTHER VISUAL INSPECTION NOTED NO WHITISH SPOTS THAT COULD INDICATE POSSIBLE OVER-TORQUEING. THE SAMPLE CONFIRMED THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A TRANSFER SET HAD LEAKED. THE TRANSFER SET WAS PUT IN PLACE ON (B)(6) 2012 AND WAS REPLACED ON (B)(6) 2012 DUE TO THE LEAK. THE SAMPLE WAS REQUESTED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11585 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10H05042

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR