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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite extension set was occluded the following information was received by the initial reporter with the following verbatim: patient is getting lipid nutrition via peripherally inserted central catheter (picc) line, and lines were changed on day shift.Throughout the night, the pump would intermittently alarm occluded.Eventually found the lipid filter tubing was clogged and not fully running the lipids properly which could cause patient to not get the correct nutrition ordered.Background: patient requires iv nutrition via her picc line due to diagnosis.
Additional Manufacturer Narrative
E4.The initial reporter also notified the fda on 25 mar, 2024.Medwatch report # (b)(4).H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported that the tubing filter would occlude.Samples arrived under (b)(4).Four samples 20127e of lot 23099461 were returned under (b)(4).The sets were visually examined for defects and abnormalities.No defects or abnormalities were observed.The received sets contained lipid solution.The sets were then primed by gravity with a 85% glycerin and 15% water solution.The sets all primed without issues, and no other failures were able to be found.The complaint of occlusion was not verified.The root cause could not be determined because the issue could not be replicated.A device history record review for model 20127e lot number 23099461 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 30sep2023.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
No additional info.

• 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: 19128794
• Report Number: 9616066-2024-00590
• Device Sequence Number: 15511389
• Product Code: FPA
• UDI-Device Identifier: 07613203019248
• UDI-Public: (01)07613203019248
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

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: 23099461
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 06/12/2024
• 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: Female