BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3841099 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17430
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE FOR THE REPORTED CONDITION WAS DETERMINED TO BE A LOOSE CONNECTION BECAUSE A LOOSE CONNECTION IS A KNOWN CAUSE OF THIS TYPE OF ALARM. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DWELL THREE OF FIVE ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE EVENT. THE HP INDICATED THAT THE CONNECTION TO A SUPPLY BAG WAS LOOSE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP IN CLEARING THE ALARM AND ENDING THERAPY. 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
    318749 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR HOMECHOICE