MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Information (3190)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : device was not returned to manufacturing facility.

Event Description

Received a copy of the customer's medwatch report from fda which states, "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." the patient impact is unknown.

Manufacturer Narrative

A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.

Event Description

Received a copy of the customer's medwatch report from fda which states, "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.".

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 16917278
• MDR Text Key: 315064809
• Report Number: 2016493-2023-161478
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: (01)10885403810015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8015.
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female