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

Catalog Number	10011865
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	02/09/2026
Type of Reportable Event	Death
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 extension set had air in line.The following information was received by the initial reporter with the following verbatim.It was reported by customer that the large amount of air emboli.Verbatim: rcc received a complaint via email.Nnp called to bedside to assess left arm with aline.Mottling noted throughout arm, chest, and back along with dec perfusion to hand.Aline removed.Ultrasounds obtained of lue and hus.Large amount of air emboli noted on hus.Pt with worsening lactate acidosis after receiving medications and intubation.Repeat hus, ct, and mri with extensive brain injury.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Correction: annex a code.H10: no product or photo was returned by the customer.The customer complaint of adverse event without identified device or use problem could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 10011865 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD ALARIS EXTENSION 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: 24604505
• Report Number: 9616066-2026-00654
• Device Sequence Number: 15705441
• Product Code: FPA
• UDI-Device Identifier: 10885403233647
• UDI-Public: (01)10885403233647
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 10011865
• Device Lot Number: UNKNOWN
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female