BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2202303 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10578
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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 REPORTED SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS A USE ERROR. THE HOME PATIENT CONNECTED TO THE CYCLER BEFORE THE PATIENT LINE WAS FULLY PRIMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. (B)(4) WAS OPENED FOR THE REPORTABLE MALFUNCTION OF A SYSTEM ERROR 2240. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    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 INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO RESTART THE SETUP WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THE REPORTED EVENT. THE HP STATED HE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THE HP STATED THE PATIENT LINE WOULD NOT PRIME COMPLETELY, THEREFORE HE CONNECTED TO THE SETUP WHILE THERE WAS STILL AIR IN THE LINE. THE HP STATED THAT HE WAS INSTRUCTED TO REPRIME THE PATIENT LINE TO REMOVE THE AIR AND THEN CONNECT. SINCE THE HP WAS MADE AWARE TO REPRIME THE PATIENT LINE TO REMOVE THE AIR, HE HAS NOT HAD ANY ISSUES SINCE. THE HP WAS ADVISED ON PROPER PROCEDURES AND STATED HE WAS DOING WELL ON THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 62 YR HOMECHOICE