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

Catalog Number	2204-0007
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
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 smartsite pump infusion set was damaged the following information was received by the initial reporter with the following verbatim it was reported by the customer that bd alaris pump infusion set correctly primed with drug and appropriately loaded into bd alaris pump channel ((b)(6)).Medication infused for 1 minute and then channel alarmed ¿air in line¿.Rn opened channel door and medication starting spraying out of a hole approximately ¼¿ below the blue housing that loads into the top of the channel.
Additional Manufacturer Narrative
One sample was returned for investigation.The set was examined for defects and abnormalities.A hole was seen at the bottom of the silicone segment.No other defects or abnormalities were observed.The customer complaint was verified.Based on the description of the leak not being discovered until after the set was inserted into the pump, the root cause of the failure is likely that the infusion set was improperly loaded causing damage to the silicone tubing of the pumping segment.Similar failures of this type have been seen when the infusion set is improperly inserted into the alaris pump.When incorrectly loading the infusion set and closing the door of the alaris pump, tears and holes in the silicone pumping segment can easily been created.
Event or Problem Description
No additional information provided.

• Brand Name: BD ALARIS SMARTSITE 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: 24327449
• Report Number: 9616066-2026-00334
• Device Sequence Number: 9674790
• Product Code: FPA
• UDI-Device Identifier: 10885403199363
• UDI-Public: (01)10885403199363(10)25116085
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 02/20/2026

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: 2204-0007
• Device Lot Number: 25116085
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/12/2026
• 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