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

Model Number 8100

Device Problems Contamination (1120); Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Lethargy (2560)

Event Date 04/10/2022

Event Type  Injury  

Event Description

It was reported that a burn patient received an over infusion of fentanyl.An infusion of fentanyl (concentration of 2500 mcg / 50 ml) was programmed to infuse at a rate of 100 mcg / hour.Subsequently, the 50ml infused within "5-10 minutes".The patient become more lethargic and experienced a "slight" drop in blood pressure.The patient was given narcan and the intravenous fluid rate was increased.The clinician indicated there was no extended harm to the patient.

Manufacturer Narrative

Bd technical support troubleshoot with customer over the phone.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.

Event Description

It was reported that a burn patient received an over infusion of fentanyl.An infusion of fentanyl (concentration of 2500 mcg / 50 ml) was programmed to infuse at a rate of 100 mcg / hour.Subsequently, the 50ml infused within "5-10 minutes".The patient become more lethargic and experienced a "slight" drop in blood pressure.The patient was given narcan and the intravenous fluid rate was increased.The clinician indicated there was no extended harm to the patient.

• 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: 14345650
• MDR Text Key: 291287550
• Report Number: 2016493-2022-139098
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 74 KG