BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4103528 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32482
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. HOWEVER, IT WAS REPORTED THAT THE PATIENT CONNECTED BEFORE THE PATIENT LINE WAS PROPERLY PRIMED, WHICH IS A KNOWN CAUSE OF THIS ALARM. 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. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET. IT ALSO INSTRUCTS THE USER TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED AND TO FOLLOW INSTRUCTIONS FOR RE-PRIMING IF THE FLUID LEVEL IS NOT NEAR THE CONNECTOR. 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

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 (AIR IN SET) ALARM OCCURRED DURING THE INITIAL DRAIN ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE EVENT. THE HP STATED AIR WAS OBSERVED IN THE PATIENT LINE. DURING TROUBLESHOOTING, THE HP STATED THAT THEY CONNECTED TO THE PATIENT LINE BEFORE IT WAS PROPERLY PRIMED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER TO CLEAR THE ALARM. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. 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
    585276 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE