MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. De C.V. BD Alaris SmartSite pump Infusion Set; Intravascular administration set

Catalog Number	2426-0007
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite 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 fluid backing up into primary drip chamber from secondary infusion.
Event or Problem Description
Sample investigation.
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
The customer reported the secondary was backflowing into the primary bag, and returned the secondary bag along with the primary suspect, the primary bag.The primary suspect is material 2426-0007, lot unknown.Upon initial visual examination, the sets had no defects or abnormalities.The sets were set up and hung with the primary on a hanger, and was run at 180 vtbi for 30 minutes on an alaris pump.The secondary set was infusing blue dyed water, and the primary tap water, in order to visualize the backflow.Even at very high flow rates, the back check valve held, and did not allow for any blue water past it towards the primary bag.The complaint of backflow could not be verified.A device history record review was not performed as the lot number is "unknown" for this complaint.The root cause of this issue could not be identified without a replicated failure.

• 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 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. De C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50808546
• Report Number: 9616066-2026-02341
• Device Sequence Number: 18789210
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K221327
• 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
• Report Date (Section B): 09/01/2026

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: 2426-0007
• Device Lot Number: Unknown
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/17/2026
• 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
• Patient Sex: Unknown