BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3872879 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18934
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A SIMULATED THERAPY AND ELECTRICAL LEAK TESTING WERE PERFORMED; NO ISSUES WERE NOTED. A REVIEW OF THE EVENT LOG WAS PERFORMED WITH A LOW DRAIN VOLUME ALARM NOTED. THE CAUSE OF THE LOW DRAIN VOLUME ALARM WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE PRESENTED AN UNSPECIFIED ALARM. IT IS UNKNOWN AT WHAT STEP OF THERAPY THE EVENT OCCURRED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350269 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1