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

Catalog Number 2434-0007

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/18/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set had flow issues the following information was received by the initial reporter with the following verbatim: can you please tell me what product lot #(10)22035121 would be associate with? i got a product concern without the manufacture number.In the comments it says there is no port above the pump segment to flush with normal saline and there is no way to connect it as a secondary.Supply chain at the site says there appears to have been a change in the tubing and where the filter is located? they were using the product to infuse amiodarone.(b)(6) 2023 internal id:(b)(4).Emergency department no harm product saved: no description: the bd alaris pump infusion set 0.2 micron filter for amiodarone that is provided will not work for a 10 minute ivpb bolus.There is no port above the pump segment to flush with normal saline and there is no way to connect it as a secondary.This pt did receive the medication over 10 minutes without a delay in care.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

Mdr to be canceled -this isn¿t a product complaint; the customer didn¿t realize the set they pulled is not manufactured with a port above the pump segment.

Event Description

Material#: 2434-0007.Batch number#: 22035121.It was reported by customer that bd alaris pump infusion set 0.2-micron filter for amiodarone that is provided will not work for a 10-minute ivpb bolus.There is no port above the pump segment to flush with normal saline and there is no way to connect it as a secondary.The pt did receive the medication over 10 minutes without a delay in care.Verbatim#: can you please tell me what product lot #(10)22035121 would be associate with? i got a product concern without the manufacture number.In the comments it says there is no port above the pump segment to flush with normal saline and there is no way to connect it as a secondary.Supply chain at the site says there appears to have been a change in the tubing and where the filter is located????? they were using the product to infuse amiodarone.(b)(6) 2023.Internal id:(b)(4).Emergency department.No harm.Product saved: no.Description: the bd alaris pump infusion set 0.2 micron filter for amiodarone that is provided will not work for a 10 minute ivpb bolus.There is no port above the pump segment to flush with normal saline and there is no way to connect it as a secondary.This pt did receive the medication over 10 minutes without a delay in care.

• 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: 18423407
• MDR Text Key: 332602915
• Report Number: 9616066-2023-02449
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019682
• UDI-Public: (01)07613203019682
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2434-0007
• Device Lot Number: 22035121
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1