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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DUO-VENT SPIKE
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BAXTER HEALTHCARE CORPORATION DUO-VENT SPIKE Back to Search Results
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988); Loss Of Pulse (2562)
Event Date 06/04/2015
Event Type  Injury  
Event Description
Probable incorrect loading of "nitroglycerin set with duo-vent spike" (baxter healthcare number (b)(4)) in a baxter iv pump (model cs2841i - single channel) led to a free-flow infusion of propofol in an ed pt previously revived from pea and cardioverted.When the propofol was hung.A rate of 3ml/hr was entered on the pump.However, 45 minutes later it was discovered that nearly the entire bottle of propofol 1000mg/100ml had infused (best guess about 85ml).Upon discovery of the infusion error the tubing was clamped, but shortly thereafter the pt's bp dropped and she lost her pulse again.Cpr was initiated and iv epinephrine administered.After several doses of epinephrine, the pt regained a pulse; but due to the pt's initial poor prognosis, the family decided to make the pt dnr-cco.Unfortunately the tubing got disconnected from the pump prior to inspection by biomed.Biomed was only able to duplicate the free flow by incorrectly inserting the tubing set so that the opaque white connector on the tubing blocked the free-flow sensor.The rigidness of this opaque connector also would not allow the pump to squeeze the tubing to deliver the correct rate of 3ml/hr.The aforementioned iv pump with a correctly inserted nitro tubing set.Medication administered to or used by the pt: no.(b)(4).
 
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Brand Name
DUO-VENT SPIKE
Type of Device
DUO-VENT SPIKE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key5406511
MDR Text Key37516905
Report NumberMW5059940
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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