BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2170564 · Received July 21, 2011

    Report

    Report Number
    1423500-2011-09278
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 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 COULD NOT BE CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS USE ERROR, THE PATIENT CUTTING THE PATIENT LINE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING ACCIDENTALLY CUTTING THE TUBING, WHICH OCCURRED ON THE HOMECHOICE DURING USE. THE PATIENT WAS CONNECTED. THE PATIENT WAS CUTTING THE TAPE AND ACCIDENTALLY CUT THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT WITH ENDING THERAPY AND REFERRED THE PATIENT TO THEIR REGISTERED NURSE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER (B)(4) CONTACTED THE PATIENT ON (B)(6) 2011 REGARDING THE REPORTED EVENT. THE PATIENT STATED THAT RIGHT AFTER THE EVENT THEY CALLED THE PERITONEAL DIALYSIS NURSE (PDN) AND LEFT A MESSAGE. IN THE MORNING THE PDN CONTACTED THE PATIENT AND THE PATIENT WENT TO SEE THE PDN. THE PATIENT STATED THEY HAVE BEEN CONTINUING THERAPY SUCCESSFULLY ON THE CYCLER SINCE THE EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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