MAUDE Adverse Event Report: CAREFUSION SD 8120 ALARIS PCA; PUMP, INFUSION

Model Number 8120

Device Problems Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

The customer¿s experience of syringe volume discrepancies was not confirmed.The pcu event log shows the last infusion on pca module s/n (b)(4) was programmed at 4:20 pm on (b)(6) 2018.The user programmed a pca dose only infusion of hydromorphone 1:1 30mg in 30ml (drugid 226) using a 35ml monoject syringe with 28.8436ml detected.Each pca request delivered 0.15ml (later changed to 0.2ml).The infusion ran until the device was channeled off at 8:37 am on (b)(6) 2018.Between 4:21 pm on (b)(6) 2018 and 8:37 am on (b)(6) 2018, there were 51 delivered pca dose requests for a total of 10.1ml and 33 requests not delivered due to the lockout interval.A determination regarding syringe volume discrepancies due to the lack of information provided.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was not returned for servicing which correlates to the customer reported issue.A trackwise complaint history review was completed, and it was confirmed that there were additional complaints received with similar sn (b)(4) for the same or related failure mode.

Event Description

The customer is requesting assistance in determining the root cause for volume discrepancies found when administering hydromorphone 1mg/ml in 30ml with a demand dose 0.02mg every 10 minutes through the pca channel.Users have found a discrepancy between the remaining volume to be infused and the expected volume.There was no patient harm.

• Brand Name: 8120 ALARIS PCA
• 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: suresh gokul selvaraj ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10872770
• MDR Text Key: 262880808
• Report Number: 2016493-2020-38454
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: 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: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 47 YR