BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3230148 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18681
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR (SE) 2240 (AIR IN LINE). THIS OCCURRED DURING PERITONEAL DIALYSIS THERAPY. THE PATIENT STATED THAT THEY HAD LEFT THE BLUE CLAMP OPEN ON THE SUPPLY LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN CLEARING THE ALARM AND ADVISED THE PATIENT TO END THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329782 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE