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

Catalog Number 2426-0500

Device Problem Defective Device (2588)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) in (b)(6).H3.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 by the customer that bd alaris pump module smartsite infusion set tubing was damaged.The following information was provided by the initial reporter with the verbatim: team has noticed 20 tubes came defective and damaged.

Manufacturer Narrative

Correction: b5: describe event or problem: it was reported, by the customer.That bd alaris pump module smartsite infusion set tubing.Was deformed damaged.The following information was provided by the initial reporter: with the verbatim: team has noticed, 20 tubes came defective and damaged.

Event Description

It was reported, by the customer.That bd alaris pump module smartsite infusion set tubing was deformed damaged.The following information was provided by the initial reporter: with the verbatim: team has noticed, 20 tubes came defective and damaged.

Manufacturer Narrative

Investigation summary: one photo was received for quality investigation.The customer complaint of misassembly was verified by evaluation of the photo provided.The photo provided by the customer indicates that the y-site smartsite was assembled incorrectly.The y-site smartsite was installed in the opposite direction of the correct installation.A device history record review for model 2426-0500 lot number 23063006 was performed.The search showed that a total of21,723 units in 1 lot number was built on 04jun2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.An investigation was conducted to determine the root cause for the issue.The manufacturing plant was notified of this defect, and an investigation was performed.The root cause was determined to be the personnel manufacturing the set.The set was not assembled per procedure and was not inspected.The involved personnel were notified of this failure and the importance of assembling sets correctly.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported by the customer that bd alaris pump module smartsite infusion set tubing was deformed damaged.The following information was provided by the initial reporter with the verbatim: team has noticed 20 tubes came defective and damaged.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17597668
• MDR Text Key: 321679567
• Report Number: 9616066-2023-01779
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: (01)37613203021006
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2426-0500
• Device Lot Number: 23063006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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