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

Model Number 8120

Device Problems Inaccurate Delivery (2339); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Oversedation (1990)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

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 that the patient was on epidural/pca of bupivacaine-hydromorphone 0.5mg.The order for infusion was 6ml continuous infusion along with a dose request 2ml bolus dose with a 20-minute lock out.The patient had experienced over sedation and as a result required narcan.On the customers internal review of the infusion report, customer stated "it looks like they only set up the 6 ml/hr.Continuous." the customer reported that there was no device malfunction.The customer is requesting the manufacturer to perform a keystroke log review to assess if any 2ml bolus doses were programmed and given.

Manufacturer Narrative

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 that the patient was on epidural/pca of bupivacaine-hydromorphone 0.5mg.The order for infusion was 6ml continuous infusion along with a dose request 2ml bolus dose with a 20-minute lock out.The patient had experienced over sedation and as a result required narcan.On the customers internal review of the infusion report, customer stated "it looks like they only set up the 6 ml/hr.Continuous." the customer reported that there was no device malfunction.The customer is requesting the manufacturer to perform a keystroke log review to assess if any 2ml bolus doses were programmed and given.

• 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: 16812693
• MDR Text Key: 313987150
• Report Number: 2016493-2023-153685
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: (01)10885403812002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043299
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2013
• 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; 8300
• Patient Outcome(s): Required Intervention