BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3191079 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16456
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO DEVICE ANALYSIS COULD BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT RECEIVED A SYSTEM ERROR 2240 (AIR IN LINE) DURING DWELL 4 OF 4 OF PERITONEAL DIALYSIS (PD) THERAPY WHILE CONNECTED TO THE HOMECHOICE (HC) WITH AN UNKNOWN BAXTER DISPOSABLE SET. THERE WAS NOTHING UNUSUAL NOTED TO THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE CAREGIVER TO RESOLVE THE ALARM AND INSTRUCTED THE CAREGIVER TO NOTIFY THE NURSE OF THE ALARM. IT WAS UNKNOWN IF THE PATIENT RESUMED THERAPY. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291061 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE