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

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Lethargy (2560)

Event Date 12/11/2022

Event Type  Injury  

Manufacturer Narrative

Bd technical support troubleshoot with customer over the phone.The event logs have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.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.No devices received, log" review only.".

Event Description

It was reported an over infusion event involving insulin on a patient who was admitted to the hospital for diabetic ketoacidosis.Insulin (100ml bag, concentration 1unit/ml) was intended to infuse at 0.1units/kg/hr.(5.3ml/hr.) as a continuous infusion and was programmed manually using guardrails drug library.It was reported that the 100ml bag appeared to have been infused in 2.5 hours instead.Due to the event, rapid response team was called due to the declining blood glucose and lethargy.Patient reportedly received dextrose 10% intravenously (several doses), dextrose 50% bolus, 3% normal saline, calcium gluconate, and supplemental oxygen due to decreasing oxygen saturation.It was reported that additional lab tests were performed to frequently check blood glucose levels, comprehensive metabolic panel, and blood gas levels.It was reported that after the event and treatments, the patient was transitioned to "normal diabetic treatment and ultimately discharged home.".

Manufacturer Narrative

It was determined through investigation of the device logs that the initially reported suspect device with serial number# (b)(6) is a concomitant and this file has captured the correct suspect device with serial number# (b)(6) as per investigation report.Omit : c20 - no findings available, d15 - cause not established.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

It was reported an over infusion event involving insulin on a patient who was admitted to the hospital for diabetic ketoacidosis.Insulin (100ml bag, concentration 1unit/ml) was intended to infuse at 0.1units/kg/hr.(5.3ml/hr.) as a continuous infusion and was programmed manually using guardrails drug library.It was reported that the 100ml bag appeared to have been infused in 2.5 hours instead.Due to the event, rapid response team was called due to the declining blood glucose and lethargy.Patient reportedly received dextrose 10% intravenously (several doses), dextrose 50% bolus, 3% normal saline, calcium gluconate, and supplemental oxygen due to decreasing oxygen saturation.It was reported that additional lab tests were performed to frequently check blood glucose levels, comprehensive metabolic panel, and blood gas levels.It was reported that after the event and treatments, the patient was transitioned to "normal diabetic treatment and ultimately discharged home.".

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): 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: 16119986
• MDR Text Key: 306880133
• Report Number: 2016493-2022-246821
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• 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; 8100(3); 8110
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 53 KG