BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2231267 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11559
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 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). 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). THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 ALARM DUE TO A USE ERROR. COMPLAINT IS CONFIRMED AND THE ASSIGNABLE CAUSE, USE ERROR WAS THAT PATIENT WAS NOT CONNECTED WHEN THERAPY INITIATED. 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CLOSE ALL OF THE CLAMPS AND TRANSFER SET AND HAD THE HP CYCLE POWER TO PRESS START TO GO PROMPT. THE TSR EXPLAINED THE ALARM AND THE CARE GIVER (CG) STATED THAT THE HP PRESSED GO PRIOR TO CONNECTING TO THE PATIENT LINE. THE TSR EXPLAINED TO DISCARD ALL OF THE SUPPLIES AND TO REPORT THE ALARMS TO THE PERITONEAL DIALYSIS NURSE THE NEXT MORNING. THE HP WOULD FINISH THE NIGHTS THERAPY MANUALLY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S (HP) WIFE ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE HP'S WIFE STATED THAT THEY STARTED OVER WITH A NEW SET UP AND EVERYTHING WENT FINE WITH THE THERAPY. THE HP'S WIFE STATED THAT THE HP HAS BEEN DOING FINE AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED.

    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