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

Model Number 8120

Device Problems Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

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.

Event Description

It was reported that fentanyl (1500mcg/30ml) was programmed to infuse 20mcg per dose request.It was alleged, however the "entire amount infused".There was patient involvement and no harm.

Manufacturer Narrative

Omit: b17 - device not returned, c20 - no findings available, d15 - cause not established.Additional information : device available for eval?, returned to manufacturer on, device return to manuf.?, device eval by manufacturer? , if other specify, imdrf annex a,g,b,c and d 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.

Event Description

It was reported that fentanyl (1500mcg/30ml) was programmed to infuse 20mcg per dose request.It was alleged, however the "entire amount infused".There was patient involvement and no harm.

• 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: 17770558
• MDR Text Key: 323680067
• Report Number: 2016493-2023-230714
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812033
• UDI-Public: (01)10885403812033
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

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: Other
• Device Model Number: 8120
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 08/26/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2013
• 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; 8120
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 95 KG