MAUDE Adverse Event Report: BECTON DICKINSON BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010453
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 of the bd alaris pump module smartsite low sorbing infusion set is occluded.The following was received by the initial reporter: verbatim: previous issues include lipids not priming through the filter, therefore they had to waste lipids by changing out the line.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 06jul2023 h6: investigation summary one sample was returned for investigation.The received set contained lipid solution which was left in the set to more closely replicate the reported event of occlusion.Prior to functional testing the set was visually examined for defects and abnormalities.Kinks were found in the tubing set and massaged out.No other defects or abnormalities were observed.Set was flushed with water and attached to an iv bag filled with 85% glycerin/ 15% water solution to be primed.An infusion run was performed at a rate of 2 ml/hr for 16hrs.No occlusions were observed during the run.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.The root cause could not be determined because the issue could not be replicated.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 dhr was performed for possible lot 23025422: a device history record review for model 10010453 lot number 23025422 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28feb2023.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
It was reported that 2 of the bd alaris pump module smartsite low sorbing infusion set is occluded.The following was received by the initial reporter: previous issues include lipids not priming through the filter, therefore they had to waste lipids by changing out the line.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17234719
• Report Number: 9616066-2023-01322
• Device Sequence Number: 12646356
• Product Code: FPA
• UDI-Device Identifier: 37613203021143
• UDI-Public: (01)37613203021143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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: Health Professional
• Device Model Number: 10010453
• Device Catalogue Number: 10010453
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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