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

Model Number	8100
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bd technical support troubleshoot with customer over the phone.The actual date of event is unknown.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 or Problem Description
It was reported that the large volume pump module was possible part of an over infusion event.There was patient involvement, but the outcome is unknown.Bd learned additional information after a cpc call with the customer: ¿ biomed ran the pcu and lvp through pm/calibration, no issues found.Alarms were tested, all operated as intended.No physical damage was noted to the devices.¿ it was said a primary infusion was to infuse over 4 hours but the bag was found empty about 1 hour and 45 minutes later when an air in line alarm occurred.However, biomed noted they do not know how much fluid was in the iv bag at the start of the infusion.Biomed questioned clinical and asked if they had enough fluid in the iv bag to last the entire infusion.The clinicians maintain that the pump allowed more fluid into the patient than intended.¿ the pcu/lvp remain sequestered.The iv set was discarded and is not available for investigation.Biomed does not intend to return the devices to bd.
Additional Manufacturer Narrative
Additional information: imdrf b code and manufacturer narrative.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.Root cause: the probable cause of the device had reported over infusion on patient was not identified during the customer call.Case escalated to dchu.However, there was no sufficient sample to address the issue.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 large volume pump module was possible part of an over infusion event.There was patient involvement, but the outcome is unknown.Bd learned additional information after a cpc call with the customer: ¿ biomed ran the pcu and lvp through pm/calibration, no issues found.Alarms were tested, all operated as intended.No physical damage was noted to the devices.¿ it was said a primary infusion was to infuse over 4 hours but the bag was found empty about 1 hour and 45 minutes later when an air in line alarm occurred.However, biomed noted they do not know how much fluid was in the iv bag at the start of the infusion.Biomed questioned clinical and asked if they had enough fluid in the iv bag to last the entire infusion.The clinicians maintain that the pump allowed more fluid into the patient than intended.¿ the pcu/lvp remain sequestered.The iv set was discarded and is not available for investigation.Biomed does not intend to return the devices to bd.

• 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: 22296330
• Report Number: 2016493-2025-88877
• Device Sequence Number: 21063299
• Product Code: FRN
• UDI-Device Identifier: 10885403211423
• UDI-Public: (01)10885403211423(11)100201
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 8100
• Device Catalogue Number: 8100 ALARIS LVP 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2010
• 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: 8015.
• Patient Sex: Unknown