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

Model Number 10010903

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Air/Gas in Device (4062)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A complaint of tubing being kinked, causing fluid blockage was received from the customer.Photos were provided for investigation.It was observed that the tubing was kinked and fully flat.The fluid did not look like it was fully flowing through the tubing, the customer complaint was confirmed.A device history record review could not be performed on model 10010903 because a lot number was not provided by the customer.Due to a physical sample not being received, a full investigation could not be performed and a root cause was not 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 smartsite gravity blood set tubing remained kinked when unclamped, causing flow issues and blockage.The following information was provided by the initial reporter: "here are some photos of problems they¿ve had with the blood tubing.When it is clamped and then unclamped, the tubing remains kinked and flow is impeded.".

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY BLOOD 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
• MDR Report Key: 12513551
• MDR Text Key: 272733119
• Report Number: 9616066-2021-52111
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203020887
• UDI-Public: 37613203020887
• Combination Product (y/n): N
• PMA/PMN Number: K882302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10010903
• Device Catalogue Number: 10010903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• 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