BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241387 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11956
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 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). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE PATIENT STATED THAT THE ONE OF THE SOLUTION BAGS BECAME DISCONNECTED; HOWEVER, THE CAUSE OF THE DISCONNECTION CANNOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE LOT NUMBER IS UNKNOWN AT THIS TIME. THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOME CHOICE (HC) AND THE HOME PATIENT (HP) STATED ONE OF THE SOLUTION BAGS BECAME DISCONNECTED AND THE HC WAS ALARM SE 2084 DURING SELFTEST. THE HP TOOK THE SET OUT AND WAS GOING TO LOAD A NEW SET AND THE SYSTEM ERROR 2084 OCCURRED. THE TSR HAD THE HP CYCLE THE POWER AND THE HC WENT TO WEIGHT. THE TSR EXPLAINED THE HP CAN DISCARD THE SUPPLIES AND START OVER WITH NEW SUPPLIES. TSR EXPLAINED THE ALARM TO THE HP AND ASSISTED WITH CLEARING THE ALARM. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP)'S DAUGHTER IN LAW (DIL) ON (B)(6) 2011 REGARDING THE CONNECTION ISSUE. PER THE DIL, SHE WAS NOT AWARE OF THE ALARM OR THE DISCONNECTION OF THE SOLUTION BAG. THE DIL WAS NOT AWARE ANY SUPPLIES THAT WOULD HAVE BEEN USED AT THAT TIME DURING THERAPY. THE DIL STATED THAT THE HP WAS IN THE HOSPITAL AND SHE WAS NOT SURE IF IT WAS PD RELATED.

    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 70 YR HOMECHOICE