BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3082988 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10671
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED ISSUE WAS NOT CONFIRMED IN THE EVENT HISTORY LOG REVIEW. PER THE SAMPLE EVALUATION, VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED AND THE REPORTED PROBLEM WAS NOT CONFIRMED. A SIMULATED THERAPY WAS PERFORMED AND COMPLETED AS INTENDED, WITH NO ISSUES OBSERVED. THE CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW AND A SERVICE HISTORY RECORD REVIEW WERE PERFORMED AND REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT VIA FAX FROM A TECHNICIAN REGARDING A HOMECHOICE (HC) MACHINE THAT HAD VARIABLE FLUID READINGS. IT WAS REPORTED THAT A PATIENT HAD A LAST INJECTION VOLUME OF 200ML PER THE PRESCRIPTION AND WHEN THE NURSE READ THE CARD, SHE OBSERVED THAT THE LAST INJECTION VOLUME VARIED WITH 200ML, 300ML, 995ML AND THEN 800ML. THE SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, BUT 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
    185456 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1