BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3851542 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-18003
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED ON AN UNSPECIFIED DATE IN OCTOBER OF 2011. AS THE DEVICE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE CAUSE OF THE REPORTED ALARM COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE UNAVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE (HC) PRO MACHINE EXPERIENCE AN UNKNOWN, AUDIBLE ALARM WITH NO MESSAGE DISPLAYED. THIS OCCURRED DURING DWELL 2 OF 5 OF PERITONEAL DIALYSIS (PD) THERAPY, WHILE THE HOME PATIENT (HP) WAS CONNECTED AND WHILE THE HEATER BAG WAS FULL. THE CARE GIVER (CG) STATED THAT THEY CLEARED THE ALARM, THE HC DEVICE ADVANCED TO THE DRAIN CYCLE, AND THE ALARM DID NOT REPEAT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG REVIEW THE ALARM LOG BUT DID NOT IDENTIFY ANY ALARMS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329216 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR