MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	11171447
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set was over infusing the following information was received by the initial reporter with the following verbatim at approx.2100, patient received approximately 297ml of d10.45 via a large infusion iv pump over 45 minutes.The pump was programmed at 7ml/hr.The neonate continues to struggle with the excess fluid it received.After the incident the iv pump, channel and tubing were secured and brought to clinical engineering for testing.No issues were found with any of the devices involved.The pump log was also examined and confirmed that the iv rate was programmed at 7ml/hr as ordered.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of overinfusion could not be verified due to the product not being returned for failure investigation.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
The patient received approx.300ml of fluid (3kg patient), resulting in fluid overload.The patient required additional medications and supports to manage the fluid.It is unknown what the long-term effects are for the patient as the patient has other medical complexities that they are also managing.No additional information provided.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21775384
• Report Number: 9616066-2025-00759
• Device Sequence Number: 8073371
• Product Code: FPA
• UDI-Device Identifier: 07613203021234
• UDI-Public: (01)07613203021234(11)240924(17)270924(10)24095343
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: Other
• Device Catalogue Number: 11171447
• Device Lot Number: 24095343
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown