BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3081483 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10578
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 7, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED THE ALARM OCCURRED DURING THE LAST NIGHT'S THERAPY. THE HP DISCONNECTIED AND TURNED THE HC OFF. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE ALARM AND THE POSSIBLE CAUSES AND ADVISED THE HP THAT THE MACHINE WAS WORKING PROPERLY. DURING TROUBLESHOOTING, THERE WAS NOTHING FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. THERE WAS PATIENT INVOLVEMENT BUT 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
    185758 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE