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

Model Number 2477-0007

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a complaint of set still infusing while clamp was engaged was received from the customer.No product or photo was returned by the customer.The customer complaint of clamp issues/ damage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2477-0007 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd alaris pump module smartsite blood infusion set tubing clamp was defective.The following information was provided by the initial reporter: "blood product infusing, saline bagged was clamped off however saline still infusing.Saline clamp verified by 2 rns.".

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE BLOOD 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: 16433599
• MDR Text Key: 310167564
• Report Number: 9616066-2023-00263
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203019478
• UDI-Public: (01)37613203019478
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894842
• 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
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2477-0007
• Device Catalogue Number: 2477-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• 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