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

Catalog Number	20127E
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite extension set flow issues the following information was received by the initial reporter with the following verbatim: lipid filter causing high pressure on picc line.Lipids unable to infuse d/t high pressure.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
It was reported that lipids occluded the filter.One sample model 20127e, lot 23099460 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Sets were flushed with water and attached to an iv bag filled with 85% glycerin/ 15% water solution and primed using.An infusion run was performed for performed for 24 hrs at a rate of 1 ml/hr.No observation of occlusions were observed.The customer complaint was unable to be replicated.See the attached ¿filtering out the facts: recommendations to optimize performance of in-line filters for parenteral nutrition and intravenous fat emulsion infusions (ivfe)¿ for additional information regarding the use of ivfe with in-line filter administration sets.Although the issue was unable to be replicated and the root cause is unknown bd is looking at opportunities to improve the filter function to alleviate this failure in the future.A device history record review for model 20127e lot number 23099460 was performed.The search showed that a total of (b)(6) in 1 lot number was built on 14oct2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SMARTSITE EXTENSION 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: 18704566
• Report Number: 9616066-2024-00237
• Device Sequence Number: 12600813
• Product Code: FPA
• UDI-Device Identifier: 07613203019248
• UDI-Public: (01)07613203019248
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 03/20/2024

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: 09/30/2026
• Device Catalogue Number: 20127E
• Device Lot Number: 23099460
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown