BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2842120 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05730
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. AS A RESULT, AN ASSIGNABLE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CONNECTION ISSUE RELATED TO TRANSFER SET FOUND DURING USE. THE HOME PATIENT(HP) REPORTED A DISCONNECTION BETWEEN TRANSFER SET AND TITANIUM ADAPTER. THE HP RECONNECTED THE TRANSFER SET TO THE TITANIUM ADAPTER AND CONTINUED TREATMENT. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 76 YR TITANIUM ADAPTER