BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241937 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-12000
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 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 LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE REPORTED EVENT. THE HP STATED SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THE HP ADVISED THAT SHE FINISHED THERAPY WITH MANUAL SUPPLIES AND RESUMED THERAPY ON THE CYCLER THE FOLLOWING DAY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE REPORTED SYSTEM ERROR 2240 ALARM WAS NOT CONFIRMED AND THE CAUSE WAS UNDETERMINED DUE TO A LACK OF SAMPLE. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER TO REPORT HAVING A SYSTEM ERROR 2240 ALARM WITH THE HOMECHOICE (HC) MACHINE DURING DWELL 3 OF 3. THE HOME PATIENT (HP) WAS STILL CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED IF ANY BAGS CAME UNDONE AND THE HP STATED NO. THE TSR EXPLAINED THE ALARM AND ASSISTED THE HP TO CLEAR THE ALARM BY TURNING THE HC OFF AND ON. THE HP WOULD FINISH WITH MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 50 YR HOMECHOICE