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

Catalog Number	2441-0007
Medical Device Problem Codes	Disconnection (1171); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
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 burette set was separated the following information was received by the initial reporter with the following verbatim it was reported by customer that rn was attempting to get air out the line and the soft portion of the tubing that goes in the pump, broke apart from the blue hard plastic portion.
Additional Manufacturer Narrative
The customer reported the tubing broke apart at the pump, and returned one used sample of material 2441-0007, lot 24125028.Upon initial visual examination, the set verified the complaint of separation at the lower fitment of the pump segment.The ring retainer was assembled onto the tubing, there is evidence of it on the silicon tubing.This little blue ring holds the pump segment together, and it was not returned.In addition, the safety clamp was disformed and broken.The root cause for the pump segment separation is not able to be traced to the manufacturing site.There is a potential clinical root cause, and a member of our clinical team was notified.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.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: ALARIS SMARTSITE
• 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: 22077823
• Report Number: 9616066-2025-01320
• Device Sequence Number: 9547873
• Product Code: FPA
• UDI-Device Identifier: 10885403235047
• UDI-Public: (01)10885403235047(11)241202(17)271202(10)24125028
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 07/15/2025

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: 2441-0007
• Device Lot Number: 24125028
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown