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

Model Number 8110

Device Problems Device Alarm System (1012); Insufficient Information (3190)

Patient Problem Extravasation (1842)

Event Date 10/27/2021

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.Device was not returned to manufacturing facility.

Event Description

It was reported that a term infant receiving a hypertonic dextrose infusion for the management of hypoglycemia developed a fulminating extravasation shortly after commencement of the infusion.This complication developed without notification of syringe pump pressure changes pertaining to a change in blood vessel compliance or early warning of infiltration by the optical sensor site monitoring technology (non-bd device) in use.The injury was extensive and treated with a hyaluronidase/saline mix subcutaneously injected into the extravasation site using established techniques.Over a period of 2 weeks, the initially deep wound healed successfully without further incident, and the infant was discharged home without evident cosmetic scarring or functional effects.

Event Description

It was reported that a term infant receiving a hypertonic dextrose infusion for the management of hypoglycemia developed a fulminating extravasation shortly after commencement of the infusion.This complication developed without notification of syringe pump pressure changes pertaining to a change in blood vessel compliance or early warning of infiltration by the optical sensor site monitoring technology (non-bd device) in use.The injury was extensive and treated with a hyaluronidase/saline mix subcutaneously injected into the extravasation site using established techniques.Over a period of 2 weeks, the initially deep wound healed successfully without further incident, and the infant was discharged home without evident cosmetic scarring or functional effects.

• 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: 12818588
• MDR Text Key: 280802096
• Report Number: 2016493-2021-70661
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403811012
• UDI-Public: (01)10885403811012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8110
• Device Catalogue Number: 8110 ALARIS SYRINGE MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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