BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2024248 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03419
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. SAMPLE IS NOT AVAILABLE.A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CALL WAS RECEIVED THROUGH BAXTER'S AFTERHOURS CALL SERVICE REGARDING A SYSTEM ERROR 2240 ALARM ON THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP TO CLOSE ALL CLAMPS ESPECIALLY THE PATIENT LINE CLAMP. HP STATED SHE COULD NOT FIND ANY CLAMPS AND SHE WILL HAVE TO WAIT FOR HER HUSBAND TO GET HOME. TSR TRIED TO EXPLAIN WHAT THE CLAMPS WERE SO SHE CAN CLOSE HER TRANSFER SET CLAMP. HP STATED SHE UNDERSTOOD WHAT TSR WAS TALKING ABOUT, BUT COULD NOT SEEM TO DO IT. TSR ADVISED TO TURN HC OFF IN THE BACK AND LEAVE IT OFF UNTIL HER HUSBAND COMES HOME. PATIENT WILL COMPLETE THERAPY WITH NEW SUPPLIES. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED. THERE WAS A PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE CYCLER