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

Catalog Number	2434-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set was damaged.The following information was received by the initial reporter with the following verbatim: it was reported by the customer that ¿pump saying air in line, opened pump to try to flick air up.Stretchy part of iv tubing was leaking with a hole noted where stretchy part meets proximal/upper connection to hard tubing.Tubing clamped then disconnected from baby.Tpn bag flipped upside down and second nurse came to take bag to prime new tubing.
Additional Manufacturer Narrative
It was reported that there was a hole in the tubing causing a leak.One sample model 2434-0007 was returned for investigation by the customer.The set was examined for defects and abnormalities.There was a hole at the top of the silicone segment.No other defects or abnormalities were observed.The customer complaint was verified.Based on the description of the leak not being discovered until after the set was inserted into the pump, the root cause of the failure is likely that the infusion set was improperly loaded causing damage to the silicone tubing of the pumping segment.Similar failures of this type have been seen when the infusion set is improperly inserted into the alaris pump.When incorrectly loading the infusion set and closing the door of the alaris pump, tears and holes in the silicone pumping segment can easily been created.A device history record review could not be performed because a lot number was not provided by the customer.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.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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: 21351779
• Report Number: 9616066-2025-00192
• Device Sequence Number: 21083529
• Product Code: FPA
• UDI-Device Identifier: 07613203019682
• UDI-Public: (01)07613203019682
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 01/23/2025

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: 2434-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/10/2025
• 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