BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3853881 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18180
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS DISCARDED BY THE USER, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN LINE/SET) ON THE HOMECHOICE DEVICE DURING CYCLE 4 OF 5 OF PERITONEAL DIALYSIS THERAPY, WHILE THE HP WAS CONNECTED. THE REPORTER STATED THAT THE SUPPLIES WERE DRY BUT THERE WAS A SMALL POOL OF SOLUTION ON THE TABLE. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332778 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE S14A08088

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE PRO