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

Catalog Number	42521E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the sets would not infuse, and returned two used sets of material 42521e and lot 23109021.Upon initial visual examination, the set(s) had no defects or abnormalities.The sets were setup to prime with water, and the failure mode of occlusion was verified.It appeared the occlusion started at the drip chamber/tubing connection.Examination under a microscope found there to be excess solvent below the drip chamber.The manufacturing site confirmed the root cause of occlusion to be excess solvent.The excess solvent was caused by an issue with the solvent dispenser, and since this batch was released there has been an upgrade to a new solvent dispenser.Device history record review for model 42521e lot number 23109021 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02oct2023.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
It was reported that bd alaris smartsite gravity set had flow issues the following information was received by the initial reporter with the following verbatim: no flow through set.Will have to get lot # from (b)(6) during your follow up.Per (b)(6), 5 occurrences over the past 2 weeks.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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: 19278614
• Report Number: 9616066-2024-00689
• Device Sequence Number: 6336157
• Product Code: FPA
• UDI-Device Identifier: 10885403274251
• UDI-Public: (01)10885403274251
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/12/2024

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 Expiration Date: 10/02/2026
• Device Catalogue Number: 42521E
• Device Lot Number: 23109021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/09/2024
• 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