BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2921604 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01360
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT FOR A REPORT OF A LEAK WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS RECEIVED BY BAXTER. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. A CLEAR PASSAGE TEST AND A CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. THE SET WAS RAN ON A HOMECHOICE MACHINE WITH NO ISSUES NOTED. THE SAMPLE COULD NOT CONFIRM THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A LOW DRAIN VOLUME (LDV) ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 1 OF 4. THE HOME PATIENT (HP) STATED THAT THE DRAIN VOLUME WAS EQUAL TO -2ML, AND THE FILL VOLUME WAS EQUAL TO 2500ML. THE HP STATED THAT THE ORGANIZER WAS WET, BUT SHE COULD NOT SEEM TO FIND WHERE IT WAS LEAKING FROM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THERAPY AND ASSISTED TO DO SO. THE TSR ADVISED THE HP TO DISPOSE OF ALL CURRENT SUPPLIES USED, EXCEPT FOR THE CASSETTE WHICH WAS REQUESTED FOR EVALUATION, AND START OVER USING ALL NEW SUPPLIES. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON (B)(6) 2013. SHE STATED THAT SHE DID NOT NOTICE ANYTHING UNUSUAL ABOUT HER SUPPLIES AT ALL THAT COULD HAVE CAUSED THE LEAK TO OCCUR. SHE DID NOT KNOW WHERE ON THE CASSETTE THE LEAK WAS COMING FROM, OTHER THAN THAT THE ORGANIZER WAS WET. SHE WAS GOING TO SEND THE SAMPLE BACK TO BAXTER THE FOLLOWING DAY. THE LOT NUMBER WAS NOT AVAILABLE. THERAPY SINCE HAS BEEN GOING WELL, AND THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28050 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE