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

Catalog Number	10942011
Medical Device Problem Codes	Separation Failure (2547); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
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 was separated.The following information was received by the initial reporter with the following verbatim as pharmacy technicians were compounding with the optima n40-o and the 10942011 alaris tubing set, the spin collar separated from the tubing set.The optima n40-o and spin collar were pulled from the tubing set and the set began leaking fluid inside the hood.
Additional Manufacturer Narrative
Investigation results: one photo taken by the customer confirms the spin collar separation from the male luer.Due to no sample being received, no root cause can be determined.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.This incident has been added to our database of reported incidents.
Event or Problem Description
Additional information from customer: the connection occurred inside the hood before priming occurred.The tube was dry and nothing leaked inside the hood.There was no reported adverse event or injury associated with this event.I do not think the detached line had anything to do with a specific phaseal because we replicated the connection outside of the cleanroom with a different phaseal.The line also detached from the spinning piece.

• 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: 24326887
• Report Number: 9616066-2026-00331
• Device Sequence Number: 21323747
• Product Code: FPA
• UDI-Device Identifier: 10885403232404
• UDI-Public: (01)10885403232404(10)25115542
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221327
• 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): 02/17/2026

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: 10942011
• Device Lot Number: 25115542
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown