BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2233237 · Received August 23, 2011

    Report

    Report Number
    2233237
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 23, 2011
    Manufacturer
    B. BRAUN
    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

    BAG #1 (DILAUDID 50MG/50ML) HUNG AT 20:29, ENDED APPROXIMATELY NEXT DAY AT 15:30. BAG #2 HUNG AT 15:49 ON SECOND DAY, RATE SET AT 2.3 ML/HR. LOCK ACTIVATED. CHARGE RN GAVE DILAUDID 0.5 MG IVP AT 21:05, NOTICING BAG "NEAR EMPTY". RN STATES THE BAG WAS EMPTY WITH MINIMAL VOLUME IN DRIP CHAMBER. CHARGE RN NOTIFIED PRIMARY RN WHO ORDERED A NEW BAG FROM PHARMACY. AT APPROX. 22:00 THE PUMP ALARMED "AIR IN LINE". RN TURNED PUMP OFF UNTIL THE NEW BAG WAS DELIVERED. PHARMACY CALLED RN STATING THE BAG SHOULD NOT BE EMPTY. IT SHOULD LAST 21-22 HRS. PATIENT STABLE. PHARMACY DISPENSED NEW BAG. AFTER RECEIVING, RN TOOK TUBING OUT OF PUMP TO CLEAR AIR OUT OF THE LINE. ONCE REMOVED, "LOCK DEACTIVATED". AFTER 3 ATTEMPTS TO RE-PROGRAM LOCK (AND ENTERING WRONG CODE), PUMP ALARMED. IT WAS THEN THAT THE PUMP WAS CHANGED AND BAG # 3 INFUSED ON NEW PUMP. BAG #3 CHARTED ON SECOND DAY AT 22:38. OLD PUMP SENT IMMEDIATELY TO BIOMED.======================MANUFACTURER RESPONSE FOR INFUSION PUMP, INFUSOMAT SPACE (PER SITE REPORTER)======================THE HOSPITAL HAS HAD MULTIPLE CALLS AND ON-SITE PRESENCE BY B.BRAUN REPRESENTATATIVES TO DISCUSS THE ON-GOING CONCERNS THE HOSPITAL HAS AND THE COMPANY IS UNABLE TO DETERMINE WHAT IS CAUSING THE PROBLEMS WE ARE HAVING WITH THE PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN 8713050U *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR