BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3140030 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13893
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THIS REPORT WAS FOR AIR IN THE TUBING DURING USE WHERE A CLAMP WAS LEFT OPEN ON AN UNUSED SUPPLY LINE. 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 AND 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. IF ANY RELEVANT INFORMATION IS OBTAINED FROM THAT REVIEW, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TROUBLESHOOTING FOR AN UNRELATED ALARM, THE CAREGIVER (CG) SAW AIR IN THE SUPPLY LINE DURING DWELL FIVE ON A HOMECHOICE (HC) MACHINE. THE CG STATED THAT THERE WAS A CLAMP OPEN ON AN UNUSED LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE ONLY CLAMPS THAT SHOULD BE OPEN ARE ON THE LINES THAT ARE USED FOR THERAPY. THE TSR THEN ASSISTED THE CG IN ENDING THERAPY AND THE CG WAS TO INFORM THE NURSE WHEN SHE ARRIVED TO RESTART WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241022 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE