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

Model Number 8120

Device Problems Break (1069); Contamination (1120); Crack (1135); Excess Flow or Over-Infusion (1311); Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2023

Event Type  Injury  

Event Description

It was reported an over infusion event involving morphine pca infusion.The event occurred on (b)(6) 2023 "between 10 and 11:30 am." the morphine infusion, total dose/volume 150mg/30ml (5mg/ml), was reportedly programmed as pca demand only dose (2mg).Due to the event, the patient was reportedly transferred to intensive care unit (icu), received narcan drip, and was discharged home after "few days.".

Manufacturer Narrative

Bd technical support troubleshoot with customer over the phone.A follow up report will be submitted once the failure investigation 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.

Event Description

It was reported an over infusion event involving morphine pca infusion.The event occurred on 30 november 2023 "between 10 and 11:30 am." the morphine infusion, total dose/volume 150mg/30ml (5mg/ml), was reportedly programmed as pca demand only dose (2mg).Due to the event, the patient was reportedly transferred to intensive care unit (icu), received narcan drip, and was discharged home after "few days.".

Manufacturer Narrative

Omit : b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.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.Investigation summary: the reported issue of an over infusion of morphine was not able to be confirmed from the log analysis or during the pca device testing.The log analysis confirmed an infusion of morphine at 150mg/30ml was programmed as a pca only infusion type with the dose at 2mg; however, the syringe type or the volume that over infused was not provided.It was reported that the volume that over infused was unknown in the returned bd investigation question the pca infusion of morphine began on the date 29nov2023 at the time of 4:39 pm.The syringe selected was a monoject 35ml syringe with a volume recorded at 29.6482ml after priming.A total of 11 pca requested infusions were performed to completion with a volume of 0.4ml (2mg of morphine) delivered.There were no unexpected alarm events that occurred during the infusions.The total volume recorded infused was at 4.4ml.The above pca infusion of morphine was continued on the date 30nov2023 with a pca dose request beginning at the time of 12:17 am.A total of 12 pca requested infusions were performed to completion with a volume of 0.4ml (2mg of morphine) delivered.There were no unexpected alarm events that occurred during the infusions.The total volume recorded infused was at 9.2ml.The pca was turned off at the time of 11:31 am.The activity that occurred during the above morphine infusion other than the pca requested infusions were pausing and restarting the pca only infusion, reviewing and clearing of the patient history.There were no events recorded that suggested the possibility of an over infusion event.The pca inspection and testing process did not find any existing malfunctions that may have caused an over infusion.The pca passed all functional and accuracy testing.During the internal inspection, damage (plastic bosses cracked/separated) was found on the front cover.This issue was determined to not have caused any functional performance issues and did not cause an over infusion.The front cover is made of the plastic material fr-110 and is affected by the recall mms-20-3882.The pca dose request cord was not provided with the pca for analysis; therefore, it could not be tested or inspected.

• 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: 18396532
• MDR Text Key: 331358549
• Report Number: 2016493-2023-251464
• 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: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• 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
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2720-2020
• Patient Sequence Number: 1
• Treatment: 8015.
• Patient Outcome(s): Required Intervention