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

Catalog Number	10012866
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
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
It was reported that bd alaris extension set was occluded the following information was received by the initial reporter with the verbatim: i am the neonatal cns at stanford children¿s hospital.We have been experiencing many issues with the 1.2 micron low protein binding filters as we spike our lipid bags and are unable to prime our lipid filter tubing, the medication will not pull through.The reference number for these products include: 10012866.Lot #: 1023119088 = 18 filters.20127e.Lot #: 1023099461 = 2 filters.Lot #: 1023099348 = 3 filters.Are there any issues that your team is aware of with these filters? any advice is appreciated.
Additional Manufacturer Narrative
The customer reported the lipid filter tubing will not prime, and returned 23 used samples of material 10012866 and lot 23119088.The sets were visually examined for defects and abnormalities.No defects or abnormalities were observed.The received sets contained lipid solution.The sets were primed by gravity with a bd administration pump set, using 85% glycerin and 15% water solution.All 23 of the sets were able to be primed in this manner, and the complaint of occlusion was unable to be verified.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.Device history record review for model 10012866 lot number 23119088 was performed.The search showed that a total of 17,603 units in 1 lot number was built on 09nov2023.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD ALARIS 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: 18472393
• Report Number: 9616066-2023-02501
• Device Sequence Number: 15052489
• Product Code: FPA
• UDI-Device Identifier: 50885403233775
• UDI-Public: (01)50885403233775
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 02/12/2024

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 Catalogue Number: 10012866
• Device Lot Number: 23119088
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown