BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022726 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03355
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE PLUS TWO COMPANION SAMPLES WERE RECEIVED AND EVALUATED. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB, THEREFORE, THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    EMAIL RECEIVED IN CORPORATE MAILBOX ON (B)(6), 2011. PATIENT REPORTED THE CASSETTE CAME LOOSE FROM THE BAG, SPRAYED SOLUTION ALL OVER THE FLOOR AND PATIENT COULD NOT COMPLETE HIS LAST FILL. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS DONE VIA PHONE. THE REGISTERED NURSE (RN) STATED THE SAMPLES PROVIDED BY THE HOME PATIENT (HP) WERE STILL AVAILABLE. THE RN STATED SHE HAD THE ACTUAL SET UP (CASSETTE AND BAGS). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10K27058

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE