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
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9616066-2023-02449
• Device Sequence Number: 18120856
• Product Code: FPA
• UDI-Device Identifier: 07613203019682
• UDI-Public: (01)07613203019682
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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
• Operator of Device: Other
• Device Catalogue Number: 2434-0007
• Device Lot Number: 22035121
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/01/2024
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown