BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4100954 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32153
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, A SUPPLY BAG DISCONNECTING WITHOUT FALLING IS A KNOWN CAUSE OF THIS ALARM. THE CAUSE OF THE DISCONNECTION COULD NOT BE DETERMINED. 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 FILL ONE ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) STATED THE HEATER BAG BECAME DISCONNECTED FROM THE RED CLAMP. THE TECHNICAL SERVICE REPRESENTATIVE (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
    584995 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOMECHOICE