BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2181438 · Received July 21, 2011

    Report

    Report Number
    2181438
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 21, 2011
    Manufacturer
    PRYOR PRODUCTS
    Product Code
    FOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    MOTHER AND PATIENT AMBULATING IN HALLWAY WITH IV POLES AND PUMPS. WALKED INTO MANAGER OFFICE AND UPON ATTEMPTING TO LEAVE, THE MOTHER LIFTED UP ON IV POLE TO CLEAR FLOOR STRIP IN DOORWAY. THE TOP HALF OF THE IV POLE CAME OFF IN THE MOTHER'S HAND WITH IV PUMP AND FEEDING PUMP ATTACHED. THE IV POLE WITH PUMP REPLACED ONTO LOWER HALF OF POLE. SUPPLY CHAIN HAS HAD STAFF REPORT THE FOLLOWING IN REGARDS TO THE IV POLE BY PRYOR, BUT HAS NO WRITTEN DOCUMENTATION:INTERNAL STAFF TRANSPORTING IV POLES TO THE PATIENT CARE AREAS AND HAVING THE POLES COME APART DURING DISTRIBUTION. INTERNAL STAFF REPORTING IV POLES COMING APART WHEN UN-STACKING THE IV POLES STORED ON THE UNITS. THERE WAS NO PATIENT HARM. THERE WAS ONE IV POLE, ONE ALARIS PUMP, AND ONE FEEDING PUMP.THE TOTAL WEIGHT OF THE PUMPS AND THE POLE IS UNKNOWN. THE IV POLE HAD HOLES ON TOP AND THE BOTTOM HALF HAD NO SCREWS. SUPPLY CHAIN STAFF HAS BEEN INSTRUCTED TO PERFORM A CHECK DURING CLEANING AND BEFORE DELIVERY. INSPECTION INCLUDES CHECKING THE POLE HAS SCREWS TO SECURE TOP HALF TO BOTTOM HALF OF IV POLE PRIOR TO SENDING TO THE UNIT FOR PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * IV STAND 6 LEGGED BASE AND 8 HOOKS FOX PRYOR PRODUCTS 915-0171 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR OTHER