BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3061698 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09411
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE BAXTER HOMECHOICE OPERATOR'S MANUAL, USERS ARE WARNED NOT TO RECONNECT DISCONNECTED SOLUTION BAGS DURING 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 SERVICE CENTER REGARDING AN ALARM WHICH OCCURRED ON THE HOMECHOICE (HC), AND DURING TROUBLESHOOTING THE HOME PATIENT (HP) STATED THAT THEY HAD REUSED SUPPLIES. THE HP HAD DISCONNECTED THE FINAL BAG AND REATTACHED IT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CLOSE THE CLAMP ON THE FINAL BAG AND GO TO THE END OF THERAPY TO DO A MANUAL DRAIN. THE TSR TOLD THE HP TO CALL THEIR REGISTERED NURSE REGARDING REUSING SUPPLIES AND ANY MISSED THERAPY. 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
    163343 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE