BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2770558 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01454
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    July 11, 2012
    Report Date
    September 18, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED TO BAXTER; THEREFORE NO EVALUATION COULD BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING A LEAK FROM A MINICAP TRANSFER SET. THE CUSTOMER STATED THAT AFTER USING THEIR TRANSFER SET FOR SEVERAL WEEKS, A LEAK WAS IDENTIFIED. THE CUSTOMER STATED THAT IT WAS DUE TO THE MAIN BODY OF TWIST CLAMP AND THAT EVEN THOUGH THE TWIST CLAMP HAD BEEN CLOSED OFF, THE SOLUTION STILL LEAKED OUT FROM TRANSFER SET. FINALLY, THE CUSTOMER VISITED THE DOCTOR AND RECEIVED A NEW TRANSFER SET. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H11F20028

    Patients

    Seq Age Sex Outcome Treatment
    1