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

Catalog Number 2420-0007

Device Problem Improper Flow or Infusion (2954)

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

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set fluid would not flush or prime through tubing.Additionally, the fluid was pulled from the primary line when it should have been pulled from the secondary line.This occurred with 3 sets during use.The following information was provided by the initial reporter: "fluid not flushing /priming through the tubing.Also cases were pulling from the primary when they should be running from secondary".

Manufacturer Narrative

H.6.Investigation summary: no product or photo was returned by the customer.It was reported by the customer "-fluid not flushing /priming through the tubing -also cases where pulling from the primary when should be running from secondary" could not be verified due to the product not being returned for failure investigation.A device history record review for model 2420-0007 and lot number 22075050 was performed.The search showed that a total of 86,403 units in 1 lot number was built on 30jul2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.H3 other text : see h.10.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set fluid would not flush or prime through tubing.Additionally, the fluid was pulled from the primary line when it should have been pulled from the secondary line.This occurred with 3 sets during use.The following information was provided by the initial reporter: "fluid not flushing /priming through the tubing -also cases where pulling from the primary when should be running from secondary".

• 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 ; 8015296192
• MDR Report Key: 15982878
• MDR Text Key: 306339675
• Report Number: 9616066-2022-01955
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 07613203021012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: 22075050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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