BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASITE FILTERED EXTENSION SET

    MDR report key: 2619993 · Received June 1, 2012

    Report

    Report Number
    2619993
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 27, 2012
    Manufacturer
    B. BRAUN OF AMERICA, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFUSION NURSE PROGRAMMED A MEDICATION THROUGH THE B. BRAUN PUMP TO RUN FOR ONE HOUR. WHEN ALARM WENT OFF INDICATING THE VOLUME WAS INFUSED, THE NURSE DISCOVERED THAT ONLY ABOUT HALF WAS INFUSED. NURSE CHANGED PUMP AND NOTIFIED BIOMED STAFF OF INCIDENT. NURSE TOOK ORIGINAL TUBING OUT OF THE AFFECTED PUMP AND CONNECTED THE TUBING TO ANOTHER PUMP AND PROGRAMMED REMAINING MEDICATION WHICH HAD ABOUT 100 CC LEFT TO INFUSE FOR LESS THAN HALF AN HOUR. ALARM WENT OFF INDICATING THE VOLUME WAS INFUSED BUT THERE WAS STILL ABOUT 50 CC LEFT SO SHE REPROGRAMMED IT AGAIN AND CHECKED IN 15 MINUTES. SHE DISCOVERED THERE WAS STILL ABOUT 30 CC LEFT, WHICH EVENTUALLY WAS INFUSED BUT TOOK TWO HOURS. NURSE DECIDED TO KEEP ORIGINAL TUBING INSTEAD OF CHANGING TUBING BECAUSE SHE DID NOT THINK IT WAS THE TUBING THAT WAS CAUSING THE PROBLEM. SHE THOUGHT IT WAS THE PUMP THAT WAS SEQUESTERED. BESIDES, SHE HAD GIVEN OVER HALF OF THE MEDICATION AND SHE CLAIMS THAT IF SHE CHANGED TUBING SHE MAY NOT BE ABLE TO ACCURATELY CALCULATE HOW MUCH MORE TO GIVE THE PATIENT. NO HARM TO PATIENT FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASITE FILTERED EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN OF AMERICA, INC 473992 0061165752
    2 INFUSOMAT SPACE PUMPS LOW ADSORPTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN OF AMERICA, INC 490037 0061161615

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES