MAUDE Adverse Event Report: CAREFUSION 303, INC. Alaris System; Pump, Infusion

Model Number	8110
Medical Device Problem Codes	Accessory Incompatible (1004); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that the syringe pump alarmed multiple times and eventually displayed a glitch screen.As a result, the nursing staff were unable to determine how much volume had been infused to the patient.The customer provided the following information: pc unit used during the incident was identified from nicu event and error logs downloaded for both pcu and syringe module.No relevant errors identified in the error logs for either device.Pcu event logs reviewed by hospital biomed: drug: alprostadil , rate: 1.39 ml/h, drug amount: 5 mcg, diluent volume: 1 ml , concentration: 5 mcg/ml , dose: 0.03 mcg/kg/min , patient weight: 3.86 kg , time units: minutes , syringe type: bd 50 ml.Event log review showed: o between 01:00 04:00, the infusor stopped and alarmed approximately 8 times prior to tubing replacement.Tubing replacement recorded at 03:13.Channel turned off at 03:54.Each alarm was followed by pump restart and reprogramming.Recorded volume infused values were inconsistent and decreased across events, indicating unreliable volume tracking, likely due to repeated restarts/reprogramming.Event sequences show the pump was repeatedly restarted immediately after occlusion alarms.Negative volumes recorded from 03:03am to 3:54 am.Following log analysis, functional inspection was performed by hospital biomed.Syringe module passed all tests on asm.Scenario reproduction performed using the same setup: syringe: bd 50 ml , vtbi: 62.7 ml, settings as per incident.Syringe finished infusion, measured volume: 61.2 ml, expected volume: 62.7 ml , error: 2.39%.During the infusion, 10 patient side occlusions were intentionally created to recreate the original scenario.The pump was also restarted without removing the occlusion, as in the original scenario.The following data was obtained with respect to the volume: rate: 1.39 ml/h occlusion volume infused (ml) v (ml) 1 57.31 0, 2 58.00 0.69, 3 57.95 0.64, 4 57.89 0.58, 5 57.82 0.51, 6 56.99 -0.32, 7 56.99 -0.32, 8 56.99 -0.32, 9 56.99 -0.32, 10 56.99 -0.32.Table 1.Change in infused volume during 10 consecutive infusions, with the syringe running at 1.39 ml/h.The yellow rows represent the occlusions where the infused volume decreased compared to the first occlusion.Same scenario was repeated with a higher rate (23 ml/h).The results also showed a small negative change in the volume: rate: 23 ml/h occlusion volume infused (ml) v (ml) 1 5.60 0, 2 5.60 0, 3 5.60 0, 4 5.60 0, 5 5.60 0, 6 5.60 0, 7 5.60 0, 8 5.60 0, 9 5.59 -0.01, 10 5.60 0.Table 2.Change in infused volume during 10 consecutive infusions, with the syringe running at 23 ml/h.The yellow rows represent the occlusions where the infused volume decreased compared to the first occlusion.The original scenario was recreated using a functional syringe pump (p119397, sn (b)(6).The syringe infused 0.58 ml and then alarmed for occlusion for the first time.A few seconds after restarting the pump, it alarmed for occlusion again.Restarting the pump was not possible after that.

• Brand Name: Alaris System
• Common Device Name: Pump, Infusion
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 25211754
• Report Number: 2016493-2026-29901
• Device Sequence Number: 10388602
• Product Code: FRN
• UDI-Device Identifier: 10885403811043
• UDI-Public: (01)10885403811043
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K211218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2026

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: 8110
• Device Catalogue Number: 8110 Alaris Syringe Module
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 07/01/2026; 07/16/2026; 08/04/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 07/15/2026; 07/21/2026; 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0185-2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015; 8600
• Patient Sex: Unknown