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

Catalog Number	2441-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
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 pump module smartsite infusion burette set was leaking the following information was received by the initial reporter with the following verbatim email summary indicated four leakage events observed in the facility for the bd alaris burette pump set.Awaiting further details.
Event or Problem Description
Additional information: primed with normal saline.Leakage was noticed during priming.4 separate events of leakage observed during priming of the set with saline prior to use on the patient.The events occured between the dates of (b)(6) 2024.
Additional Manufacturer Narrative
Additional information in section b investigation result: no 2441-0007 sample was available for investigation.The customer reported that the affected sample was from lot 24045417 and "leakage observed during preparation".As part of the investigation, the customer provided a video of the affected sample; analysis of the video confirmed the customer's experience, with leakage visible from two smartsites.A closer inspection confirmed that the smartsites were oval in shape.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 24045417 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note, the root cause of the oval smartsite is exposure of the smartsite to an external heat source that brings the component temperature above 60°c.The piston head of the smartsite is oval-shaped therefore when the round female luer adaptor (fla) component is placed over it, the piston opening is squeezed shut in order to create a seal.Under excessive heat conditions, the fla material can soften, and as the piston pushes back on the inside, it can reshape the fla to conform to the original oval-shape of the piston head.A review of the manufacturing process, bd storage conditions, and sterilization process has not found a potential root cause for this level of excess heat.The quality team at the manufacturing site has been informed of this report and will continue to monitor the incoming feedback and remain vigilant to issues of this nature during future production.A review of the customer feedback database indicates that reports of this nature against the smartsite component are rare and have been occurring at a low frequency within the last 12 months.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION 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: 21092512
• Report Number: 9616066-2025-00005
• Device Sequence Number: 12995536
• Product Code: FPA
• UDI-Device Identifier: 10885403235047
• UDI-Public: (01)10885403235047(11)240423(17)270423(10)24045417
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 01/29/2025

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: 24045417
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown