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

Catalog Number 2426-0007

Device Problem Improper Flow or Infusion (2954)

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

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set had air in line the following information was received by the initial reporter with the following verbatim: describe the event or problem: s: iv tubing noted with unusual bubble.B: iv tubing was beeping just after nurse had primed and started pump to infuse.Upon investigation of iv infusion site and clamps, everything was fine.Nurse restarted infusion and pump immediately alarmed again.Nurse opened lvp (large-volume parenteral) and noted a bubble.A: tubing was taken down and replaced with new tubing.No bubbles noted after starting infusion with new tubing.

Manufacturer Narrative

E4.The initial reporter also notified the fda on xx jan, 2024.Medwatch report # (b)(4).If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of air bubbles / air in line could not be verified due to the product not being returned for failure investigation.A device history record review for material# 2426-0007 and lot# 23109373 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6)2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

Event Description

No additional info.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18785280
• MDR Text Key: 337438273
• Report Number: 9616066-2024-00318
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: (01)10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2426-0007
• Device Lot Number: 23109373
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 34 KG