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

Model Number	2865
Medical Device Problem Codes	Device Alarm System (1012); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
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 while infusing lactated ringers iv fluid the device produced an error, reading "fault 282- motor motion hindered".There was patient involvement but no harm.
Additional Manufacturer Narrative
Omit : b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.Additional information : device eval by manufacturer?, reason code for no evaluation, if other specify, imdrf annex a, b, c, d, g codes and manufacturer narrative.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.H3 other text : not applicable.Device evaluated by bd.
Event or Problem Description
It was reported while infusing lactated ringers iv fluid the device produced an error, reading "fault 282- motor motion hindered".There was patient involvement but 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: 17629130
• Report Number: 2016493-2023-219781
• Device Sequence Number: 7748880
• Product Code: FRN
• UDI-Device Identifier: 10885403928659
• UDI-Public: (01)10885403928659
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K933545
• 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): 10/05/2023

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: 2865
• Device Catalogue Number: 2865 ALARIS MSIII 5.0 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2016
• 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