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

Catalog Number	10942011
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
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 pump infusion set was separated the following information was received by the initial reporter with the following verbatim.It was reported by customer that air noticed in line on large volume alaris "pump infusion set" when trouble shooting air, tubing disconnected from blue cassette (the portion that loads into pump) and began leaking tpn.The line is cut and tied in a knot.
Additional Manufacturer Narrative
The customer reported the tubing was alarming air in line, and then found to be leaking when the pump was opened.One tubing set of material 10942011, lot unknown was returned.Upon initial visual examination, the set verified the complaint of leakage, and separation at the lower fitment of the pumping segment.The little blue ring retainer is responsible for maintaining the connection with the silicon, and the safety clamp.This ring retainer was not returned with the set.There is evidence on the silicon tubing that the ring retainer was assembled.The tubing was also cut off before the male luer, as reported by the customer.The root cause for the pump segment separation is not able to be traced to the manufacturing site.There is a potential clinical root cause, and a member of our clinical team was notified.A device history record review could not be performed because the lot number is unknown.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: 22435392
• Report Number: 9616066-2025-01861
• Device Sequence Number: 4592908
• Product Code: FPA
• UDI-Device Identifier: 10885403232404
• UDI-Public: (01)10885403232404
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K221327
• 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): 07/16/2025

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: 10942011
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/08/2025
• 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