BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2180238 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09763
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED, AND THE ROOT CAUSE WAS UNDETERMINED. THE REPORT OF AIR IN LINE WAS NOT CONFIRMED AND A CAUSE OF THE AIR WAS NOT DETERMINED.SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. A LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A LOW DRAIN VOLUME ALARM OCCURRED ON HOME CHOICE (HC) DURING USE DURING INITIAL DRAIN. THE CARE GIVER(CG) STATED THAT THE PATIENT LINE WAS FULL OF AIR AND THE HOME PATIENT (HP) HAD DISCONNECTED TO TRY TO DRAIN THE LINE. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) ADVISED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. THERE WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1