BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3173051 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15566
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 23, 2013
    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). THE SAMPLE WAS UNAVAILABLE FOR FURTHER INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS NOT AVAILABLE; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A TRANSFER SET THAT DISCONNECTED FROM A PATIENT LINE WHILE THE PATIENT WAS PERFORMING PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE LOOSE CONNECTION WAS UNKNOWN. THE PATIENT REMAINED WELL AND WAS GIVEN A LOADING DOSE OF ANTIBIOTICS AS A PRECAUTION FOR THE ACCIDENTAL DISCONNECTION. FURTHER TREATMENT WAS NOT REQUIRED. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273686 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR HOMECHOICE PEDIATRIC LOW REC VOLUME