BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2221093 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11149
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 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 THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED AND THE ROOT CAUSE WAS UNDETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DURING A CALL WHERE THE CUSTOMER MENTIONED DISSATISFACTION ON THE HOME CHOICE (HC), THE CUSTOMER REPORTED THEY HAD A SYSTEM ERROR (SE) 2240. THE HOME PATIENT (HP) REVEALED THERAPY WAS NOT DISCONTINUED PRIOR TO THE COMPLETION OF THE FIRST TWO CYCLES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS TILL THE PATIENT RECEIVED A NEW MACHINE. DURING A FOLLOW-UP WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) REGARDING THE REPORTED PROBLEM, THE PD RN STATED THE PATIENT DID TALK TO THEIR PRIMARY NURSE. THE PD RN STATED THAT THE PATIENT HAS BEEN CONTINUING THERAPY WITHOUT FURTHER PROBLEMS AND HAS NOT BEEN HINDERED. THERE WAS PATIENT INVOLVEMENT BUT 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 38 YR HOMECHOICE