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

Catalog Number	10011865
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris pump infusion set had air bubbles / air in line.The following information was provided by the initial reporter: filter attachments dispelling air from them when tilted side to side lot number (10)25019439.2 filters tried with same results.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Three samples were received for quality evaluation.The extension sets were primed and checked for leaks and any air-in-line or bubbles in the line.None were identified.The extension sets were then connected to a sample bd primary infusion set and tested during a simulated infusion at a rate of 125 ml/hr.There were not issues of leakage, occlusion, air-in-line or air bubbles identified with the samples submitted.The customer complaint of air bubbles.Air-in-line could not be replicated.A root cause investigation was not conducted because the reported issue could not be replicated in the samples submitted.A device history record review for model 10011865 lot number 25019439 was performed.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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23372135
• Report Number: 9616066-2025-03242
• Device Sequence Number: 10089755
• Product Code: FPA
• UDI-Device Identifier: 10885403233647
• UDI-Public: (01)10885403233647(17)280130(10)25019439
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 10011865
• Device Lot Number: 25019439
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown