BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4102822 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32326
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, IMPROPERLY DISCONNECTING/RECONNECTING FROM THE SET IS A KNOWN CAUSE OF THIS ALARM. 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 HAS INSTRUCTIONS ON THE STEPS TO PROPERLY DISCONNECT FROM CYCLER DURING AN EMERGENCY AND EXPLAINS HOW TO RECONNECT FOR THERAPY AFTER PROPERLY DISCONNECTING. 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 ALARM (AIR IN SET / LINE) OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING DRAIN FOUR OF FOUR OF PERITONEAL DIALYSIS THERAPY. THE HOME PATIENT (HP) WAS NOT CONNECTED AT THE TIME OF THE ALARM. DURING THE TROUBLESHOOTING, IT WAS DETERMINED THAT THE HP HAD DISCONNECTED FROM THE SET USING ASEPTIC TECHNIQUE AND THEN RECONNECTED BACK. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP IN CLEARING THE ALARM. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES OR USE CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) TO COMPLETE THE THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583996 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR HOMECHOICE