MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D LOW SORB SS 1.2M; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10010453
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.4.The initial reporter also notified the fda on (b)(6) 2023 medwatch report # mw5118818.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 of the bd alaris¿ lvp 20d low sorb ss 1.2m experienced under infusion.The following information was provided by the initial reporter: customer reported when hanging nightly iv lipids, the 1.2-micron filter was not filling all the way / finishing priming (with 2 different sets of iv tubing).When writer notified pharmacy, writer was told that certain filters haven't been working correctly lately.It seemed to be the iv tubing sets with lot # (10)22125416.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that when hanging nightly iv lipids, the 1.2-micron filter was not filling all the way / finishing priming (with 2 different sets of iv tubing).The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 10010453 lot number 22125416 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that 2 of the bd alaris¿ lvp 20d low sorb ss 1.2m experienced under infusion.The following information was provided by the initial reporter: customer reported when hanging nightly iv lipids, the 1.2-micron filter was not filling all the way / finishing priming (with 2 different sets of iv tubing).When writer notified pharmacy, writer was told that certain filters haven't been working correctly lately.It seemed to be the iv tubing sets with lot # (10)22125416.

• Brand Name: BD ALARIS¿ LVP 20D LOW SORB SS 1.2M
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17418829
• Report Number: 9616066-2023-01565
• Device Sequence Number: 7145060
• Product Code: FPA
• UDI-Device Identifier: 07613203021135
• UDI-Public: 07613203021135
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 12/13/2025
• Device Catalogue Number: 10010453
• Device Lot Number: 22125416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown