MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE ADD-ON BURETTE SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	82113E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
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 the bd alaris smartsite add-on burette set had a loose connection.The following information was provided by the initial reporter: the needle-free valve (burette) defected in outpatient dialysis par cart.The spike connector was not secured properly.Not safe for patient treatment.Removed and replaced with new sets.
Additional Manufacturer Narrative
One photo was returned by the customer.Evaluation of the photo provided indicates that the tubing above the drip chamber, with spike connected to it, separated from the full assembly.The customer complaint of connection issues could not be verified, however, separation of the upper spike and tubing was determined.Investigation was forwarded to manufacturing to determine if root cause analysis is possible.After the investigation, the failure mode was confirmed but the exact root cause could not be determined.The potential cause of separation between tubing and spike could be related to an incorrect solvent application by the assembler or issues with the solvent dispenser.No corrective actions were taken at the manufacturing location of this production batch because that manufacturing location has been deactivated.We will continue to track and trend and if any negative trend is observed, proper actions will be deemed necessary for the next scheduled production at the new manufacturing location.A device history record review for model 82113e lot number 25019315 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 ADD-ON BURETTE 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: 22797156
• Report Number: 9616066-2025-02395
• Device Sequence Number: 20960381
• Product Code: FPA
• UDI-Device Identifier: 07613203009591
• UDI-Public: (01)07613203009591(17)280114(10)25019315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K780130
• 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): 10/22/2025

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: 82113E
• Device Lot Number: 25019315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown