BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3951738 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23785
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT DURING USE, WHERE THE CALLER STATED THEY HAD ATTACHED A NEW SUPPLY BAG TO THE SUPPLY LINE. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿ WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. SECTION ¿TROUBLESHOOTING¿ INSTRUCTS THE USER NOT TO ATTEMPT TO REUSE ANY DISPOSABLE SUPPLIES. SECTIONS ¿WARNINGS AND CAUTIONS¿, ¿PERFORM THERAPY¿, AND ¿TROUBLESHOOTING¿ WARNS THE USER NOT TO REPLACE EMPTY SOLUTION BAGS OR RECONNECT DISCONNECTED SOLUTION BAGS DURING THERAPY. SECTIONS ¿WARNINGS AND CAUTIONS¿, ¿PERFORM THERAPY¿, ¿END THERAPY¿, AND ¿TROUBLESHOOTING¿ WARNS THE USER THAT POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF AN UNRELATED ALARM, IT WAS REPORTED THAT THE CALLER HAD ATTACHED A NEW SUPPLY BAG TO THE SUPPLY LINE. THE EVENT OCCURRED DURING THERAPY ON THE HOME CHOICE (HC). NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430920 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE