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

Model Number 2420-0500

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd alaris pump module smartsite infusion set there was a blockage and air was trapped in the line.There was no report of patient impact.The following information was provided by the initial reporter verbatim.Describe the event or problem: "bd alaris infusion set would not let medication infuse, 2 sets with this issue.Medication would not flow through tubing, despite the clamps all being open and the little fill cannister at the top was full.The second infusion set was filled with large air pockets in tubing, and it also would not flow.Unfortunately, tubing was not saved.".

Event Description

It was reported while using bd alaris pump module smartsite infusion set there was a blockage and air was trapped in the line.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: describe the event or problem: bd alaris infusion set would not let medication infuse, 2 sets with this issue.Medication would not flow through tubing, despite the clamps all being open and the little fill cannister at the top was full.The second infusion set was filled with large air pockets in tubing, and it also would not flow.Unfortunately, tubing was not saved.

Manufacturer Narrative

Investigation summary: three photos were returned by the customer.It was reported by the customer that one bd alaris infusion set would not let medication infuse, and second infusion set was filled with large air pockets in tubing, and would also not flow.The photos show the packaging of the sets.However, they do not verify the complaint.The root cause of this failure was not identified as no product was returned, therefore the failure could not be replicated.A device history record review for model 2420-0500 lot number 23013089 was performed.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 PUMP MODULE SMARTSITE INFUSION SET
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16987746
• MDR Text Key: 316448494
• Report Number: 9616066-2023-00991
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: (01)37613203012448
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 23013089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1