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 Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

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

Event Date 04/12/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set infused zosyn in minutes despite the infusion being set for over 3 hours.The following information was provided by the initial reporter: "patient event reported with zosyn, which should have infused over 3 hours, infused in minutes this infusion was delivered as a secondary infusion.Primary had been infusing without any issues prior to the zosyn.No patient harm reported".

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint that there was over-infusion could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set infused zosyn in minutes despite the infusion being set for over 3 hours.The following information was provided by the initial reporter: "patient event reported with zosyn, which should have infused over 3 hours, infused in minutes a.This infusion was delivered as a secondary infusion.D.Primary had been infusing without any issues prior to the zosyn.J.No patient harm reported".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16865866
• MDR Text Key: 314888860
• Report Number: 9616066-2023-00817
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 07613203012430
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• 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
• Treatment: UNSPECIFIED BD¿ SECONDARY IV SET.