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 Product Quality Problem (1506)

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

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 a bd alaris pump module smartsite infusion set the tubing had no connector.There was no report of patient impact.The following information was provided by the initial reporter: the primary iv tubing came out of the package without a connector on the patient end.

Event Description

It was reported while using a bd alaris pump module smartsite infusion set the tubing had no connector.There was no report of patient impact.The following information was provided by the initial reporter: the primary iv tubing came out of the package without a connector on the patient end.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09sep2022.H6: investigation summary: one sample was received for quality investigation.The customer complaint of misassembly was verified by visual inspection.Evaluation of the sample received shows that the male luer connector at the end of the assembly is missing.Further evaluation of the tubing where the luer was to be connected indicates that there is no sign of solvent on the tubing.A device history record review for model 2420-0500 lot number 22033263 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0500 lot number 22033219 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set a device history record review for model 2420-0500 lot number 22033264 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set a device history record review for model 2420-0500 lot number 22033214 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set based on the results from the investigation and the description of the events provided by the customer, the root cause for the failure is that the infusion set was packaged without the male luer connector assembled on the infusion set.The manufacturing location was informed of the issue and process improvement steps have been put into place to correct this issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 15478598
• MDR Text Key: 306339735
• Report Number: 9616066-2022-01404
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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