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

Model Number	8120
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual date of event is unknown.A device history record, complaint history review, and risk review on failure modes are performed on each device with reportable malfunction(s) along with other methods of investigation as coded in section h6 of this mdr report.Investigation summary: the report of the infusion history that appeared erased was confirmed.The external and internal inspection was unable to be performed due to no devices being returned for investigation.A bd consultant identified that the clinician selected a drug with a different drug id and the system treated the programming as a new drug event.Between 1:52 pm and 1:54 pm the unit was selected, the syringe type was bd plastipak 50 ml, drugid 472 suspected to be ¿hydromorphone custom¿ was programmed for a pca only infusion with a vtbi of 47.1674 ml, and the infusion started.At 4:55 pm the unit was selected, the syringe type was changed to bd plastipak 50 ml, (drugid 477) suspected to be ¿hydromorphone¿ was programmed for a pca only infusion with a vtbi of 49.7845 ml, and the infusion started.No laboratory testing was able to be performed on the reported devices as they were not returned for investigation.The alaris system is not intended to replace supervision by medical personnel.The user must become thoroughly familiar with the alaris system features, operation, and accessories prior to use.There was patient involvement with no harm.Root cause: the root cause for the reported infusion history that appeared erased was identified due to a user error.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
On (b)(6) 2025, during a patient controlled analgesia (pca) infusion of hydromorphone, a clinician reported that infusion history from 07:15 to 16:55 appeared erased when replacing the medication cartridge at 16:55.A preliminary review by a bd interoperability consultant confirmed that the initial syringe was programmed using guardrails hydromorphone custom (drug id 472).When the second syringe was installed, the clinician selected guardrails hydromorphone (drug id 477).Because the drug id changed between cartridges, the system behaved as designed and treated the programming as a new drug event, which clears the prior infusion history.Customer confirmed no adverse event occurred and confirmed event was attributed to a guardrails workflow issue.There was patient involvement with no harm.

• 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: 24588121
• Report Number: 2016493-2026-13006
• Device Sequence Number: 21178612
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: (01)10885403812002
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K043299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 8120
• Device Catalogue Number: 8120 ALARIS PCA 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: 03/05/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2014
• 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 (2)
• Patient Sex: Unknown