BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1243116 · Received November 21, 2008

    Report

    Report Number
    1423500-2008-00925
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ACCORDING TO THE PT'S NURSE, THE SAMPLE WAS DISCARDED WHEN THE PATIENT HAD THE TRANSFER SET REPLACED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR CODE 2240 THAT OCCURRED ON THE HOME CHOICE (HC) DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CLEARED THE ALARM AND ADVISED TO CONTACT THE NURSE. A FOLLOW UP CALL WAS MADE TO THE NURSE IN (B) (6) 2008. THE NURSE STATED THE ALARM WAS CAUSED WHEN THE TRANSFER SET CAME OFF THE CATHETER. THE TRANSFER SET WAS LOOSE AND SHE DID NOT NOTICE ANY DEFECTS WITH THE TRANSFER SET. THE SAMPLE WAS DISCARDED WHEN THE PT CAME IN TO HAVE THE TRANSFER SET REPLACED. THE PT HAD NO INJURIES RELATED TO THE EVENT. THE HC UNIT WAS OPERATIONAL. NO PT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP 78KDJ KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1