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

Model Number	8100
Medical Device Problem Codes	Crack (1135); Excess Flow or Over-Infusion (1311); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was an over infusion event.Infusion initiated at 1346 and the container emptied at 1405.Upon observation, the pump was set at the right rate and volume, however the infusion finished 11 minutes early.There was patient involvement, but no harm.
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.
Additional Manufacturer Narrative
Correction: it was determined through investigation of the returned devices that the initially reported suspect device reported under manufacturer report number 2016493-2025-79534 is a concomitant.Please refer to manufacturer report number 2016493-2025-79533 which captured the correct suspect device per investigation report.
Event or Problem Description
It was reported there was an over infusion event.Infusion initiated at 1346 and the container emptied at 1405.Upon observation, the pump was set at the right rate and volume, however the infusion finished 11 minutes early.There was patient involvement, but no harm.
Additional Manufacturer Narrative
This follow-up report is to correct the manufacturer narrative reported under 2016493-2025-79534 follow-up #1.Upon further review of the investigation, it was revealed that the device s/n (b)(6) had malfunctions that are deemed mdr reportable.The malfunctions are listed in the imdrf annex a grid section of this follow-up report.
Event or Problem Description
It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no patient involvement associated for the reported failure as it was observed by the manufacturer during servicing activity.

• 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: 22000752
• Report Number: 2016493-2025-79534
• Device Sequence Number: 15270705
• Product Code: FRN
• UDI-Device Identifier: 10885403211423
• UDI-Public: (01)10885403211423(11)091222
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 505
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 07/15/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/04/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2009
• 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
• Patient Sex: Unknown