BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2882287 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07828
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS CONFIRMED DURING THE SAMPLE EVALUATION; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. A VISUAL INSPECTION WAS PERFORMED WITH A CUT IN THE TUBING NOTED. LEAK TESTING WAS PERFORMED WITH A LEAK AT CUT NEAR SLEEVE NOTED. A CLEAR PASSAGE TEST WAS PERFORMED WITH NO ISSUES NOTED. A CLAMP FUNCTION TEST WAS PERFORMED WITH NO ISSUES NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER (B)(4) REGARDING A LEAK FROM A MINICAP TRANSFER SET. THE NURSE STATED THAT THE PATIENT HAD BEEN LEAKING PD FLUID OVERNIGHT FROM MINISET, THE PATIENT WAS BROUGHT TO THE HOSPITAL THE FOLLOWING MORNING, THE MINISET WAS CHANGED AND HE WAS GIVEN PREVENTATIVE ANTIBIOTICS. THE NURSE STATED SHE HAD NOT SEEN A SPLIT TO OCCUR WHERE IT DID ON THE SET, AND IT "HAD NOT BEEN CAUSED BY ANY IMPLEMENT OR MALICIOUS ACT". THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT. DURING A FOLLOW-UP WITH THE NURSE, SHE STATED THE HOME PATIENT (HP) IS FINE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO