BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3833815 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17098
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AIR IN THE CASSETTE, INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE, WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED, A DEVICE ANALYSIS CANNOT BE COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) OBSERVED AIR BUBBLES INSIDE OF THE CASSETTE (NOT THE TUBING) OF AN AUTOMATED PD SET WITH CASSETTE. THIS WAS NOTICED DURING AN UNSPECIFIED STEP OF PERITONEAL DIALYSIS (PD) THERAPY. IT IS UNKNOWN WHETHER THE HP WAS CONNECTED TO THE SETUP AT THE TIME OF THE OBSERVATION. THE HP STATED THAT THEY HAD BEEN PERFORMING PD THERAPY FOR 12 YEARS AND NEVER HAD A PRIOR ISSUE LIKE THIS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311466 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H14C12052

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE