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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS; PUMP, INFUSION

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CAREFUSION 303, INC. ALARIS; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 01/09/2023
Event Type  malfunction  
Event Description
A phenylephrine infusion was started during induction of anesthesia for a patient undergoing a coronary artery bypass graft (cabg).Several minutes into induction, the patient became hypertensive (systolic blood pressure (bp) 180s baseline --> 140s shortly after propofol --> 200-210s).The phenylephrine infusion was paused on the pump, but the patient continued to be hypertensive and the bp did not come down despite additional propofol, fentanyl, and repeated boluses of nicardipine and nitroglycerin.The bp gradually decreased after induction was completed and no more boluses of medication were given, and sbp dropped to 100s systolic after the phenylephrine infusion was disconnected from the peripheral iv.At this point, the phenylephrine bag (starting volume 250ml) was noted to be half empty despite the infusion only running for a few minutes at a low rate.The infusion programming rate was confirmed to be the correct dose (0.3 mcg/kg/min) and the patient's weight was also correctly programmed so this was not a programming error.Suspect that the pump free flow mechanism was broken because at no point did the pump alarm that the door was open.Likely severe hypertension was related to bolusing other medications in the same iv line which effectively meant large doses of phenylephrine were simultaneously bolused due to the amount of medication remaining in the bag an hour after the infusion was started.The pump was removed from service and a tag was placed to explain the issue to clinical engineering.
 
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Brand Name
ALARIS
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key16775805
MDR Text Key313667570
Report Number16775805
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8100
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/09/2023
Event Location Hospital
Date Report to Manufacturer04/20/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/20/2023
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18615 DA
Patient SexFemale
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