BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4123328 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33492
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYSTEM ERROR (SE) 2240 (AIR IN LINE/SET) ON THE HOMECHOICE (HC) DEVICE DURING AN UNSPECIFIED STEP OF PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE PATIENT HAD DISCONNECTED TO USE THE RESTROOM AND RETURNED TO THE ALARMING HC MACHINE. THE PATIENT STATED THAT THEY THEN RESET THE MACHINE AND CONTINUED THERAPY WITHOUT FURTHER ISSUES. THE PATIENT HAD RECONNECTED, BUT IT WAS NOT SPECIFIED WHETHER THEY HAD RECONNECTED BEFORE RESTARTING THERAPY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602859 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE