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

Catalog Number 2420-0500

Device Problem Air/Gas in Device (4062)

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

Event Date 03/14/2024

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.Nurses have started to notice that the iv tubing (of the type i gave you a package from) at least some of the time is not clearing of air when we prime the tubing.The nurses are priming as usual, but they¿re seeing a length of tubing that doesn¿t have fluid in it.This is concerning, because we could miss this if we don¿t specifically look for it.They describe a length of tubing a foot or more that doesn¿t prime with fluid.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

Correction on event date from 03/18/2024 to 03/14/2024.

Event Description

Nurses have started to notice that the iv tubing (of the type i gave you a package from) at least some of the time is not clearing of air when we prime the tubing.The nurses are priming as usual, but they¿re seeing a length of tubing that doesn¿t have fluid in it.This is concerning, because we could miss this if we don¿t specifically look for it.They describe a length of tubing a foot or more that doesn¿t prime with fluid.Response: attached are three separate incidences regarding this tubing issue.I will check on the status of any samples and any adverse effects.My apologies for the delay in responding.I was out of the office and i logged this issue with the bd rep on 3-14-24 and i had not heard back about follow steps so i was unprepared to offer coverage while i was out of the office.No actual patient harm occurred, however medication administration was slowed down somewhat by checking the tubing for air and completing further priming prior to being able to hook up the tubing to the pump.This has happened on several patients so far.No sample provided yet¿i¿ll re-remind staff that i need samples.

• 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: 19061112
• MDR Text Key: 339885434
• Report Number: 9616066-2024-00545
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: (01)07613203012430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• 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
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0500
• Device Lot Number: 24015077
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1