BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBRAUN INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP

    MDR report key: 2060068 · Received April 4, 2011

    Report

    Report Number
    2060068
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 28, 2011
    Manufacturer
    B.BRAUN MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THREE PUMPS WERE STACKED ON EACH OTHER. WHEN THE NURSE WAS GOING TO INSERT THE TUBING IN THE BOTTOM PUMP, THE TWO BOTTOM PUMPS FELL OFF THE MAIN TOP PUMP AND HIT THE BED. THEY DID NOT HIT THE PATIENT,HOWEVER THE CENTRAL VENOUS PRESSURE (CVP) LINE WAS PULLED OUT IN THE PROCESS.IT WAS LATER DETERMINED THAT THE WAY THE PUMPS LOCK TOGETHER AND UNLOCK WHEN YOU STACK THEM IS NOT INTUITIVE TO THE STAFF. THE STAFF FORCED THE LOCKING MECHANISMS TO OPEN ESSENTIALLY BREAKING THEM. THE NEXT TIME THEY WERE USED THEY HAD THE POTENTIAL TO FALL OFF AS THIS ONE DID. LATCHES ON OVER 30 PUMPS HAD TO BE REPLACED DUE TO DAMAGE THAT STAFF CAUSED BY FORCING THE PUMPS TO RELEASE.====================== MANUFACTURER RESPONSE FOR IV PUMP, BBRAUN INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP======================UNSURE AS OF TODAY.====================== MANUFACTURER RESPONSE FOR LATCHES, SERVICE KIT BBRAUN INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP======================UPON ORDERING THE LATCHES TO FIX THE ISSUE, THEY WERE BACKORDERED FOR SEVERAL WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBRAUN INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN B.BRAUN MEDICAL, INC. 8713050U *
    2 SERVICE KIT BBRAUN INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP LATCHES FRN B.BRAUN MEDICAL, INC. 34521593 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *