BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3973860 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25135
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER H14E07057 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION NOTED. THE DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION IDENTIFIED THREE HOLES IN THE PATIENT LINE TUBING. FUNCTIONAL TESTING WAS ALSO PERFORMED ON THE AUTOMATED PERITONEAL DIALYSIS (APD) SET WITH CASSETTE. LEAK TESTING VERIFIED A LEAK FROM THREE HOLES IN THE PATIENT LINE TUBING. CLAMP FUNCTION TEST AND CLEAR PASSAGE TEST WAS PERFORMED WITH NO ISSUES NOTED. THE APD SET WITH CASSETTE WAS RUN ON THE HOMECHOICE DEVICE WITH NO ALARMS NOTED. THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS RELATED TO THE REPORTED EVENT DUE TO HOLES IN THE PATIENT LINE. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A LEAK IN THE PATIENT LINE DURING THERAPY WITH A HOMECHOICE AUTOMATED PD SET WITH CASSETTE. THE HOME PATIENT (HP) OBSERVED A HOLE IN THE PATIENT LINE WHERE THE LEAK WAS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP IN STARTING OVER THERAPY WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451249 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H14E07057

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE