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

Catalog Number	10010903
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite gravity blood set was leaking the following information was received by the initial reporter with the following verbatim it was reported by customer that they had a different issue with the blood set.At the beginning of a case, one of their colleagues brought the patient into the or and noticed a large puddle below the iv sets.When examining the cause, he found one of the bags to be empty.There are two lines leading up from the drip chamber, and one was completely gone.I don¿t know if it was there in the first place and popped out, or if it was missing from the beginning.But the line had not been used and was never under tension that we know of.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: the customer reported one of the drip chamber spikes was gone, and returned the used set of material 10010903, lot 24129114.Upon initial visual examination, the set verified the failure, and only one spike and tubing was attached at the top of the drip chamber.The second tubing and spike was not returned with the set.The set was examined under a microscope, and insufficient solvent was found on the drip chamber joint.The manufacturing plant found the root cause for the blood tubing spike separation to be related to incorrect solvent assembly process.The plant did not take any actions to address the failure as the line for material 10010903 was reactivated at a different bd plant, starting 10mar2025.The plant that produced this batch is no longer producing the material number.The new plant issued a quality alert on june 05, 2025, to communicate and reinforce the correct solvent assembly procedure.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
Sample.

• Brand Name: BD ALARIS SMARTSITE GRAVITY BLOOD 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: 22005917
• Report Number: 9616066-2025-01196
• Device Sequence Number: 15216698
• Product Code: FPA
• UDI-Device Identifier: 07613203020879
• UDI-Public: (01)07613203020879(11)241206(17)271206(10)24129114
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050115
• 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): 06/16/2025

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: 10010903
• Device Lot Number: 24129114
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown