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 Problem Convulsion/Seizure (4406)

Event Date 09/15/2022

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 that an infusion of a bag containing 500 ml of lidocaine in d5w (4 mg/ml) was infused when only 308 ml was expected to have infused.A copy of the medwatch report from fda was received, which states,"code blue was called following o2 desat to 79%.Patient experienced seizure with shock.Patient was on lidocaine infusion for pain for the two days prior leading up to event.Lidocaine level checked and came back elevated on the following day.The attached pump report shows accurate pump programming per epic orders.However, the 500 ml bag of lidocaine was replaced the day before and only 308 ml of lidocaine should have infused by that time.Her clinical presentation (seizure and shock) and lidocaine level are suggestive of lidocaine toxicity.It is not clear if there was a lidocaine overdose or the patient was simply not clearing the drug normally.".

Event Description

It was reported that an infusion of a bag containing 500 ml of lidocaine in d5w (4 mg/ml) was infused when only 308 ml was expected to have infused.A copy of the medwatch report from fda was received, which states,"code blue was called following o2 desat to 79%.Patient experienced seizure with shock.Patient was on lidocaine infusion for pain for the two days prior leading up to event.Lidocaine level checked and came back elevated on the following day.The attached pump report shows accurate pump programming per epic orders.However, the 500 ml bag of lidocaine was replaced the day before and only 308 ml of lidocaine should have infused by that time.Her clinical presentation (seizure and shock) and lidocaine level are suggestive of lidocaine toxicity.It is not clear if there was a lidocaine overdose or the patient was simply not clearing the drug normally.".

Manufacturer Narrative

Omit : b17 - device not returned, c20 - no findings available, d15 - cause not established.Correction : medical device serial #, device manufacture date.Additional information: device available for eval, returned to manufacturer on, report source, device return to manuf, device eval by manufacturer, if other specify, imdrf annex a, b, c, d, g codes and 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.H3 other text : not applicable.Device evaluated by bd.

• 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: 15593218
• MDR Text Key: 301627465
• Report Number: 2016493-2022-206634
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2019
• 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(2); 8110
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female