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

Catalog Number	INCORRECT ENTRY
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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 set was separated the following information was received by the initial reporter with the following verbatim.It was reported by the customer that nurse spiked the bottle and was about to squeeze the drip chamber and noticed two long cracks on the chamber.The tubing fell apart into 3 separate segments.The nurse did not apply any unordinary force to the tubing during handling.The nurse manager inspected it and found it had separated at the backflow valve just beneath the drip chamber.The nurse did not apply any unordinary force to the tubing during handling.The nurse manager inspected it and found it had separated at the backflow valve just beneath the drip chamber.It also separated at the last y-site.
Additional Manufacturer Narrative
One sample model 2426-0500, lot 24093183 was returned for investigation.The set was examined for defects and abnormalities.The drip chamber has two cracks on it, the inlet back check valve port was broken and the inlet distal y-site port was broken.The packaging returned at cuts in it.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the most probable cause of the damage is damage during shipping.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.
Event or Problem Description
No additional information.

• 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: 22142910
• Report Number: 9616066-2025-01483
• Device Sequence Number: 8215640
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: (01)07613203020992(11)240909(17)270909(10)24093183
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 07/08/2025

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: INCORRECT ENTRY
• Device Lot Number: INCORRECT ENTRY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown