BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1862365 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04209
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    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). THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. THE LABELING WAS FOUND ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2267 WHICH OCCURRED ON THE HOME CHOICE (HC) DURING DWELL 3 OF 6. THE HOME PATIENT (HP) STATED THAT THE UNUSED CLAMPS WERE ALL OPEN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP THAT UNUSED LINES SHOULD BE CLAMPED DURING THERAPY. THE TSR ENDED THERAPY AND ADVISED THE HP TO NOTIFY THE PERITONEAL DIALYSIS NURSE OF THE MISSED THERAPY. THE HC WAS OPERATIONAL. 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 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1