BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2180530 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09787
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 10, 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). CORRECTION:INFORMATION WAS ERRONEOUSLY OMITTED FROM PREVIOUS SUBMISSIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION REPORTED BY THE CUSTOMER. THE COMPLAINT WAS CONFIRMED THROUGH GLOBAL TECHNICAL SERVICES TROUBLESHOOTING AND CAUSE WAS IDENTIFIED AS USE ERROR. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE WAS FOUND TO BE ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SAMPLE IS NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW -UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A CHECK LINES AND BAGS ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING PRIME. THE HOME PATIENT (HP) WAS NOT CONNECTED. THE HP STATED THEY CHANGED THE CASSETTES ON THE SETUP TWO TIMES BUT THEY DID NOT CHANGE THE SOLUTION BAGS. GTS EXPLAINED THE PROPER SETUP OF SUPPLIES. THE HP WILL START OVER WITH NEW CASSETTE AND SOLUTION BAGS. THE HC UNIT WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT, BUT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE