BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3900543 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20694
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS REPORTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET/LINE) ALARM OCCURRED DURING USE ON THE HOMECHOICE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THERE WAS NOTHING FOUND DURING TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN CLEARING THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377672 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE