BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2071308 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05111
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED AS THIS WAS A USE ERROR.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). THE SYSTEM ERROR (SE) 2240 WAS IDENTIFIED DURING A REVIEW OF A RETURNED HOMECHOICE (HC) DEVICE WITH OCCURRENCE ON (B)(4) 2011; THERE WAS NO REPORT FOR THIS ALARM CALLED IN BY THE CUSTOMER. THERE IS NO EVIDENCE THAT PROBLEMS WITH THE HC CONTRIBUTED TO SE 2240. A ROOT CAUSE WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(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. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE NURSE. THE NURSE WENT TO CYCLE THE POWER OFF AND ON AND NEVER CAME BACK TO THE PHONE. THE HC UNIT WAS OPERATIONAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. THE NURSE WAS CONTACTED AND STATED THAT THE PATIENT IS NOT A FULL-TIME PERITONEAL DIALYSIS PATIENT. THE NURSE STATED THAT THE CAUSE OF THE ALARM WAS THAT AIR WAS PULLED THROUGH THE LAST TWO LINES BECAUSE THE SOLUTION BAGS WERE NOT CONNECTED. THE NURSE STATED THIS WAS AN ISOLATED EVENT AND THE PATIENT WAS DISCHARGED WITH NO ADVERSE EVENTS OR MEDICAL INTERVENTION. NO OTHER INFORMATION WAS AVAILABLE AT THIS TIME.

    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 CYCLER