BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT

    MDR report key: 1802002 · Received August 16, 2010

    Report

    Report Number
    6000001-2010-02600
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF WORN OUT AND SPLIT WAS CONFIRMED. VISUAL INSPECTION WAS PERFORMED TO THE SET AND THE RESULTS WERE SATISFACTORY; ALL COMPONENTS WERE PRESENT, IN THE RIGHT POSITION AND COMPLETE. FUNCTIONAL TEST AND A PRESSURE TEST UNDER WATER AT 8.0 PSI +/- 0.5 PSI OF AIR WAS APPLIED TO THE SET. THE ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON RECEIPT AND COMPLETION OF THE EVALUATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED TO PROVIDE THE RESULTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP HAD A DAMAGED BATTERY. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. DURING REVIEW OF THE PUMP'S EVENT HISTORY, BAXTER PERSONNEL CONFIRMED THE REPORTED CONDITION AS A BATTERY DEPLETED ALARM, AND DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTINUOUS 72HR INFUSION WAS BEING PERFORMED WITH SIGMA SPECTRUM PUMP, (B)(4) TOWARDS THE END OF THE INFUSION ON (B)(6) 2010, THE TUBING INSIDE THE PUMP GOT WORN OUT AND SPLIT, CAUSING AN UNKNOWN SOLUTION TO LEAK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1