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

Catalog Number	2260-0500
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
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 infusion set had flow issues.The following information was received by the initial reporter with the following verbatim it was reported by customer that the spiked albumin unable to fill line even with vent open.Only with full force pressing into rubber stopper did albumin start to fill and stopped when pressure released.After filling the line halfway, it started to fill as normal and had no further issue.
Additional Manufacturer Narrative
One sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and unable to be primed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, it was not possible to confirm that the condition reported is related to manufacturing process.A device history record review for material# 2260-0500 and lot# 24115303 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13nov2024.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 MODULE 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: 22598401
• Report Number: 9616066-2025-02122
• Device Sequence Number: 4083750
• Product Code: FPA
• UDI-Device Identifier: 07613203012591
• UDI-Public: (01)07613203012591(11)241113(17)271113(10)24115303
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 2260-0500
• Device Lot Number: 24115303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown