BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120574 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07446
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A LEAK WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. PER THE COMPLAINT INFORMATION, THE LEAK WAS CAUSED DUE TO THE HOME PATIENT WHO DISCONNECTED, WHICH CAUSED THE LINES TO DRIP. LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IDENTIFIED IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED THAT THE LINE WAS DRIPPING BECAUSE THE HOME PATIENT (HP) DISCONNECTED FROM THE HOMECHOICE (HC) MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CAREGIVER (CG) PRESS STOP AND END OF THERAPY. THE TSR ASKED IF THE HP USED A MINI CAP AND ASEPTIC TECHNIQUE WHEN HE DISCONNECTED. THE CG STATED YES. THE TSR SUGGESTED THE HP CONTACT THE DIALYSIS NURSE AND DO A MANUAL EXCHANGE. PRODUCT SURVEILLANCE ATTEMPTED TO CONTACT THE NURSE ON (B)(6) 2011. A DETAILED MESSAGE WAS LEFT FOR THE NURSE NOTIFYING HER OF THE LEAK. THE NURSE WAS ADVISED TO CALL BACK SHOULD SHE HAVE ANY QUESTIONS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    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 73 YR HOMECHOICE