MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. ALARIS; 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	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 gravity blood set was leaking the following information was received by the initial reporter with the following verbatim it was reported by customer that upper seal of hand pump on bd smartsite gravity blood set (hand pump blood tubing) failed while squeezing hand pump, causing blood to spray caregiver.The area in which the blood leaked/sprayed out of was covered in a tegaderm for easier identification of defect.
Additional Manufacturer Narrative
The customer reported leaking from the top of the blood tubing hand pump, and returned the used set of material 10010903, lot 25029328.Upon initial visual examination, the set verified the failure, due to the reported tegaderm around the leak, and the dried blood on the outside of the tubing.The tegaderm was removed from the set.The set was then infused with water and the hand pump was filled, and pressure applied by hand.There was no leak from the water, even under extra pressure.The issue could not be replicated.Without a replicated failure, the root cause for the issue could not be determined.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.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.
Event or Problem Description
No additional information was provided.

• Brand Name: ALARIS
• 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: 22189668
• Report Number: 9616066-2025-01552
• Device Sequence Number: 15542734
• Product Code: FPA
• UDI-Device Identifier: 07613203020879
• UDI-Public: (01)07613203020879(10)25029328
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/14/2025

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: 25029328
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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