BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3851984 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-18052
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. A CLEAR PASSAGE TEST AND PRESSURE TEST WERE PERFORMED WITH NO ISSUES NOTED. A DIMENSIONAL ANALYSIS WAS PERFORMED ON THE SPIKE PORT WITH ALL MEASUREMENTS WITHIN SPECIFICATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAK WAS OBSERVED BETWEEN THE CONNECTION OF THE CASSETTE AND A SOLUTION BAG. THE EVENT OCCURRED DURING PRIME ON THE HOME CHOICE (HC). NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329120 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE