BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2002978 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02523
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 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 WAS DISCARDED; HOWEVER, A COMPANION SAMPLE AND LOT INFORMATION WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED SAMPLE WAS RECEIVED IN REFERENCE TO THE SYSTEM ERROR (SE) 2240 ALARM. THE SET WAS PLACED ON A MACHINE FOR PRIMING AND NO ALARMS WERE NOTED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THIS REPORT WAS NOT CONFIRMED. THE BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 3 OF 5. GTS HAD THE PATIENT CYCLE POWER TWICE TO THE "PRESS GO TO START" PROMPT. GTS THEN ADVISED THE PATIENT TO START OVER WITH NEW SUPPLIES AND EXPLAINED THAT AIR HAD ENTERED INTO THE DISPOSABLE SET. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED THAT NO LEAKS OR HOLES WERE DETECTED. THE PATIENT STATED THE SAMPLE WAS DISCARDED BUT WAS ABLE TO PROVIDE A COMPANION SAMPLE AND THE LOT INFORMATION. NO INJURY OR MEDICAL INTERVENTION WAS 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 H10L12041

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE CYCLER (B)(4)