BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2111756 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-07003
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 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 A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS NOT CONFIRMED. THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE CAUSED BY THE PATIENT NOT BEING CONNECTED WHEN THERAPY INITIATED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOMECHOICE (HC) DURING DWELL 1. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP). THE TSR HAD THE HP CYCLE THE HC. THE SE 2367 OCCURRED. THE TSR INFORMED TO START OVER USING NEW SUPPLIES. DURING TROUBLESHOOTING, TSR DOCUMENTED THAT THE PATIENT HAD CONNECTED AFTER REALIZING THEY PRESSED GO WITHOUT BEING CONNECTED. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE NURSE REGARDING THE ALARM. THE NURSE STATED THAT THE PATIENT HAD VISITED THE CLINIC AND HAD BEEN CONTINUING THERAPY WITH NO ISSUES. THE NURSE HAD REVIEWED PROCEDURES FOR THERAPY WITH THE PATIENT.

    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 53 YR HOMECHOICE