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

Model Number	8015
Medical Device Problem Codes	Device Alarm System (1012); Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that the pc unit (software version 12.3.1.2) had a system error (error code 9-1513-202) during simulation testing.The user was initially attempted to recreate an issue ¿without a max in the pca and then adding it in after the infusion started¿ and the user was unable to recreate a system error at that time¿.A few hours later, the user stated that the device ¿suddenly got a system error¿.The user was unable to silence the alarm.None of the modules were infusing at the time.The programming that the user was doing was ¿ketamine greater than 45kg concentration 500mg/50ml pca dose 10 mg lockout interval 15 minutes and continuous dose 15mg/hr.No max and then start and once started went back and added a max¿.The user reportedly initially did this several times without an error.As previously stated, a few hours later, while sitting in standby with device turned on without an infusion running, it went into system error.There was no patient involvement as the event occurred in a test environment.
Event or Problem Description
It was reported that the pc unit (software version 12.3.1.2) had a system error (error code 9-1513-202) during simulation testing.The user was initially attempted to recreate an issue ¿without a max in the pca and then adding it in after the infusion started¿ and the user was unable to recreate a system error at that time¿.A few hours later, the user stated that the device ¿suddenly got a system error¿.The user was unable to silence the alarm.None of the modules were infusing at the time.The programming that the user was doing was ¿ketamine greater than 45kg concentration 500mg/50ml pca dose 10 mg lockout interval 15 minutes and continuous dose 15mg/hr.No max and then start and once started went back and added a max¿.The user reportedly initially did this several times without an error.As previously stated, a few hours later, while sitting in standby with device turned on without an infusion running, it went into system error.There was no patient involvement as the event occurred in a test environment.
Additional Manufacturer Narrative
Omit: c20 - no findings available, d15 - cause not established.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.

• Brand Name: ALARIS SYSTEM
• Common Device Name: 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: 19402558
• Report Number: 2016493-2024-27231
• Device Sequence Number: 17836924
• Product Code: FRN
• UDI-Device Identifier: 10885403517921
• UDI-Public: (01)10885403517921
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K211218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8015
• Device Catalogue Number: 8015 ALARIS PCU 1.5 MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100.; 8110.; 8120.
• Patient Sex: Unknown