BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3032398 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08206
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT ARE UNKNOWN. THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 DURING THE INITIAL DRAIN STAGE. THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THERE WAS NO REPORT OF ISSUES THAT MIGHT HAVE CAUSED THE ALARM. ALTHOUGH THE REGISTERED NURSE STATED SHE WAS NOT SURE IF THE PATIENT LINE WAS FULLY PRIMED OR NOT WHEN SHE CONNECTED, INSUFFICIENT INFORMATION WAS PROVIDED TO DETERMINE THE CAUSE OF THE ALARM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN TUBING) DURING INITIAL DRAIN ON THE HOME CHOICE (HC). THE REGISTERED NURSE (RN) STATED SHE WAS NOT SURE IF THE PATIENT LINE WAS FULLY PRIMED OR NOT WHEN SHE CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE RN TO END THERAPY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136684 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE