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

Catalog Number 11532269

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ low sorbing infusion set had a one inch cut in the tubing and leaked most of the medication onto the floor.The following information was provided by the initial reporter: "today during an infusion our nursing staff identified a 1 inch cut in the tubing.This was found after the majority of the iv leaked on the floor.I examined the tubing myself and spoke with my technician that prepared the iv and tubing.There were no sharp objects used that could have led to us cutting the tubing.".

Manufacturer Narrative

Investigation summary: a complaint of a cut in the tubing causing leakage was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 11532269 lot number 21116350 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 25nov2021.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.

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING 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: 16449084
• MDR Text Key: 310439035
• Report Number: 9616066-2023-00275
• Device Sequence Number: 1
• Product Code: FPA
• 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
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11532269
• Device Lot Number: 21116350
• 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
• Date Device Manufactured: 11/24/2021
• 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