BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4202618 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37522
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A CLAMP BEING LEFT OPEN ON AN UNUSED LINE IS A KNOWN CAUSE OF THIS ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿ WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER TO MAKE SURE ALL CLAMPS ON UNUSED FLUID LINES ARE CLOSED SECURELY WHEN PERFORMING PERITONEAL DIALYSIS (PD) THERAPY. THE GUIDE INSTRUCTS THE USER TO CLOSE ALL CLAMPS WHILE PREPARING TO LOAD THE DISPOSABLE SET. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR, AIR IN SET/LINE ALARM OCCURRED ON THE HOMECHOICE DEVICE DURING DWELL ONE OF FIVE. THE HOME PATIENT (HP) WAS NOT CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, IT WAS NOTED THAT THERE WAS AN OPEN CLAMP ON ONE OF THE UNUSED LINES. THE TECHNICAL SERVICE REPRESENTATIVE REVIEWED PROPER PROCEDURES WITH THE HP AND ADVISED THE HP TO BEGIN THERAPY AGAIN WITH ALL NEW SUPPLIES. THE HP WOULD COMPLETE THERAPY USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684757 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE