BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1771019 · Received July 27, 2010

    Report

    Report Number
    1423500-2010-01658
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) UNIT. TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT AT SOME POINT, THE HC DETECTED THAT AIR HAD BEEN PULLED INTO THE SET UP. THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN. PRODUCT SURVEILLANCE CONTACTED HOME PATIENT'S NURSE REGARDING A SYSTEM ERROR 2240 ALARM. THE NURSE STATED THAT THE HOME PATIENT HAS BEEN DOING FINE AND HAS BEEN ABLE TO CONTINUE THERAPY OK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE CLIPS STAYED OPEN AFTER FIRING, ONLY THE TIPS CLOSED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS PROLONGED THIRTY MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR