BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1891906 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05367
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION/ADDITIONAL INFORMATION: THE INFORMATION WAS INADVERTENTLY OMITTED IN THE PREVIOUS MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF LOW ALARM VOLUME WAS DUPLICATED DURING THE EVALUATION PERFORMED BY THE PAL (PRODUCT ANALYSIS LAB). THE ALARM VOLUME WAS FOUND TO BE VERY WEAK AT THE MAXIMUM SETTING. THE SPEAKER WAS REPLACED AND THE SPEAKER VOLUME RETURNED TO NORMAL. THE ASSIGNABLE CAUSE FOR THE LOW ALARM VOLUME WAS DETERMINED TO BE THE SPEAKER ON THE DIGITAL/ACCOMP HARNESS. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE LOW ALARM VOLUME. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN ISSUE WITH HEARING THE ALARMS ON A HOMECHOICE (HC) DURING USE. THE REGISTERED NURSE (RN) STATED THAT THE HOME PATIENT (HP) WAS UNABLE TO HEAR THE ALARMS AT THE LOUDEST SETTINGS. THE RN REQUESTED A SWAP OF THE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE MACHINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1