MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 8300

Device Problems Use of Device Problem (1670); Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2023

Event Type  malfunction  

Event Description

It was reported that a review of the all infusion detail report revealed a discrepancy on the pca module lockout interval programming, the order was hydromorphone (dilaudid) 1mg/ml pca, patient bolus: 0.2mg, lockout interval: 10 minutes, continuous dose: 0mg/hr., one hour dose limit: 1.5mg, and loading dose: 0.2mg.However, the report states that a "6-minute lockout interval" had been programmed.The report also showed that 0.2 mg of a loading dose was delivered and an additional 1 mg of pca dose delivered over the duration of this pca infusion.It was documented in the electronic medical record (emr) that about 26ml of drug was discarded from a 50ml syringe.The emr also showed that the scheduled start date/time was "(b)(6) 2023 1415" and end date/time was (b)(6) 2023 1923." the customer is requesting bd to find out the following through review of the device logs: what was the syringe selected? what was the volume assessed in the syringe at the start and at the end? was priming used for this pca? are there any etco2 alarms that fired? was the infusion shut off at all during the duration of delivery? there was patient involvement, but it is unknown if there was harm.Although requested, additional information was not provided.

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.H3 other text : no devices received, log review only.

Manufacturer Narrative

It was determined through investigation of the devices 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.Correction : describe event or problem, medical device type, common device name, medical device catalog #, unique identifier (udi) #, medical device serial #, medical device model #, pma / 510(k)#, device manufacture date.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 a review of the all infusion detail report revealed a discrepancy on the pca module lockout interval programming, the order was hydromorphone (dilaudid) 1mg/ml pca, patient bolus: 0.2mg, lockout interval: 10 minutes, continuous dose: 0mg/hr., one hour dose limit: 1.5mg, and loading dose: 0.2mg.However, the report states that a "6-minute lockout interval" had been programmed.The report also showed that 0.2 mg of a loading dose was delivered and an additional 1 mg of pca dose delivered over the duration of this pca infusion.It was documented in the electronic medical record (emr) that about 26ml of drug was discarded from a 50ml syringe.The emr also showed that the scheduled start date/time was "06/07/23 1415" and end date/time was "06/07/23 1923." the customer is requesting bd to find out the following through review of the device logs: what was the syringe selected? what was the volume assessed in the syringe at the start and at the end? was priming used for this pca? are there any etco2 alarms that fired? was the infusion shut off at all during the duration of delivery? there was patient involvement, but it is unknown if there was harm.Although requested, additional information was not provided.Bd learned additional information from the customer, who reported that they've conducted their own analysis of the device logs and provided the following information: pump had the latest dataset pump was on guardrailsprogramming matched the pca order at the time the pump was programmed at 14:10 lockout 6 min, pca dose 0.2mg, loading dose 0.2mg, one hr.Dose limit 2mg total of 1.2mg hydromorphone was given over the span of 2 hours 1410 loading dose 0.2mg 1421 1st pca dose 0.2mg 1432 2nd pca dose 0.2mg 1553 3rd pca dose 0.2mg 1601 4th pca dose 0.2mg 1610 5th pca dose 0.2mg the order was changed at 1656 and verified at 1658 for lockout 10min, one hr.Dose limit 1.5mg the customer is requesting bd to assist with reviewing the logs and answer the following questions: 1.What syringe was selected during setup? 2.Was the etco2 module functioning (paused 3 times) and were there any etco2 alarms that fired? 3.What was the volume infused? a.50ml dispensed.B.1.2 ml given.C.26 ml wasted per rn note at 4:44pm d.22.8 ml unaccounted for, of which some would be used for priming and possibly noted in the keystroke log.

• Brand Name: ALARIS SYSTEM
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• 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: 17245785
• MDR Text Key: 318453183
• Report Number: 2016493-2023-190093
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: (01)10885403830013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8300
• Device Catalogue Number: 8300 ALARIS ETCO2 MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2013
• 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; 8100