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

Catalog Number	2260-0500
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned by the customer and the provided photo does not show the sample or confirm reported issues.The customer complaint of flow issues - accuracy could not be verified due to the product not being returned for failure investigation.A device history record review for material# 2260-0500 and lot# 25045043 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02apr2025.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported that bd alaris pump infusion set had flow issues the following information was received by the initial reporter with the following verbatim it was reported by customer that "overinfusion".
Additional Manufacturer Narrative
Testing of sample infusion set conducted under bd complaint pr (b)(4).Visual inspection of the infusion set was conducted and there were no anomalies observed.Testing was conducted at flow rates of 0.1 ml/h, 1 ml/hr, 10 ml/hr, 100 ml/hr and 99 ml/hr.No instances of unregulated flow were observed.The customer complaint of flow issues - accuracy was not confirmed.A root cause analysis was not conducted because the failure was not replicated.A device history record review for material# 2260-0500 and lot# 25045043 was performed.The search showed that a total of 42,243 units in 1 lot number was built on 02apr2025.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS PUMP 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: 22935468
• Report Number: 9616066-2025-02619
• Device Sequence Number: 9755654
• Product Code: FPA
• UDI-Device Identifier: 07613203012591
• UDI-Public: (01)07613203012591(11)250402(17)280401(10)25045043
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: Other
• Device Catalogue Number: 2260-0500
• Device Lot Number: 25045043
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown