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

Catalog Number 2477-0007

Device Problem Improper Flow or Infusion (2954)

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

Event Date 02/05/2023

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Investigation summary: no product or photo was returned by the customer.It was reported by customer that "saline clamp was closed but appears to still have been infusing diluting the blood that was already infusing." the customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 2477-0007 lot number 22095260 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6)2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 had flow issues with the prbc bag infusing less than the pump stated, as well as saline infusing into the blood and diluting it despite the saline clamp being closed.The following information was provided by the initial reporter: "rn was administering 1 unit prbc.When checking on blood and volumes already infused- the blood volume infused on pump was more than volume in bag and there was still blood in bag to be infused.Prbc bag volume was 300.Pump saying around 500 was infused.Rn noticed blood was lighter than normal and saline bag volume was down.Saline clamp was closed but appears to still have been infusing diluting the blood that was already infusing.".

• 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: 16583357
• MDR Text Key: 312284958
• Report Number: 9616066-2023-00518
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: 07613203019460
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2477-0007
• Device Lot Number: 22095260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 20 KG
• Patient Race: White