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

Catalog Number	10015012
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
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 separeated the following information was received by the initial reporter with the following verbatim it was reported by the customer that line broke at connection site just above safety clamp / at the bottom of the soft portion of tubing that goes into the pump.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Correction: medical device catalog #.Possible lot # is 25085214.H10: it was reported by the customer that line broke at connection site just above safety clamp/at the bottom of the soft portion of tubing that goes into the pump.One sample was received for quality evaluation.Visual inspection indicates that the tubing set separated at the lower pumping segment fitting to the silicone tubing.Further examination indicates that the securement collar looks to have been on the assembly because there is an indention of the collar on the silicone tubing.The customer complaint of separation was confirmed.The investigation was forwarded to manufacturing for further investigation and possible root cause analysis.Based on the description of the failure and examination of the sample indicating that the set was assembled correctly, it was determined that the infusion separated after the infusion set was handled by the customer.Therefore, the root cause of the failure is not related to the manufacturing process.A probable cause for the issue could be the way the customer handled the product that may have caused the infusion set to separate.However, without further details on the use of the product, a definitive root cause could not be established.A device history record review for model 10015012 lot number 25085214 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 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: 24423830
• Report Number: 9616066-2026-00487
• Device Sequence Number: 5878442
• Product Code: FPA
• UDI-Device Identifier: 10885403233951
• UDI-Public: (01)10885403233951
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• 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): 04/10/2026

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: 10015012
• Device Lot Number: INCORRECT ENTRY
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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