BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3030828 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08096
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE PROPER ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING AIR IN THE DISPOSABLE CASSETTE'S PATIENT LINE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING PERITONEAL DIALYSIS, DRAIN 3 OF 4. THE CAREGIVER (CG) STATED THAT THE PATIENT LINE DISCONNECTED FROM THE TRANSFER SET AND FELL ON THE FLOOR, AND THE HOME PATIENT (HP) HAD RECONNECTED IT. IT WAS UNKNOWN HOW THE PATIENT LINE BECAME DISCONNECTED FROM THE TRANSFER SET. THERE WAS VISIBLE AIR IN THE PATIENT LINE SO THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG WITH THE ENDING THERAPY EARLY PROCEDURE. THE TSR ADVISED THE CG TO NOTIFY THE HP'S RN AS SOON AS POSSIBLE. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CG. 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
    134572 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR HOMECHOICE