BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 4802947 · Received May 28, 2015

    Report

    Report Number
    1416980-2015-23225
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 14, 2015
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET/LINE) ALARM OCCURRED DURING DWELL FIVE OF SIX OF PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THERE WAS NOTHING FOUND DURING TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ALARM. 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
    344930 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE S15A26055

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE