BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120199 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07435
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 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). THE SAMPLE LOT NUMBER IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A CHECK PATIENT LINE ALARM WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE PATIENT DID NOT DESCRIBE ANY TYPE OF USE ERROR THAT MIGHT HAVE CAUSED THE ALARM. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM; WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DRAIN 1 OF 4. THE HP STATED THEY COULD SEE AIR IN THE PATIENT LINE. THE TSR RECOMMENDED THE HP START OVER WITH NEW SUPPLIES. DURING A FOLLOW-UP ON (B)(6) 2011, THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) WAS CONTACTED REGARDING THE REPORTED PROBLEM. THE PD RN STATED THAT THE HP'S THERAPY HAS BEEN GOING WELL OVERALL, SINCE THEY HAVE NOT RECEIVED A CALL RECENTLY. 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 82 YR HOMECHOICE