MAUDE Adverse Event Report: BD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 20350E

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Device Contamination with Chemical or Other Material (2944)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd alaris¿ smartsite¿ low sorbing extension set tpn line was blocked, building pressure in the chamber and causing tpn fluid backing up from the filter to turn "cloudy".The following information was provided by the initial reporter: "the tpn line was blocked and pressure building up in the chamber, all vents opened and clamps unclamped.Second rn to verify and troubleshoot, had same issue.Tpn fluid backing up from filter into chamber appearing cloudy.Unable to pull air bubbles out with syringe.Disconnected line to try to run fluid through it, and completely blocked with all clamps opened.Defective iv tubing.".

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the tpn line was blocked and pressure building up in the chamber, fluid backing up from filter into chamber appearing cloudy 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.A trend for this occlusion issue has been identified for this product line.Capa#1998036 has been initiated, and a team has been assembled in order to investigate the issue.

Event Description

It was reported that the bd alaris¿ smartsite¿ low sorbing extension set tpn line was blocked, building pressure in the chamber and causing tpn fluid backing up from the filter to turn "cloudy".The following information was provided by the initial reporter: "the tpn line was blocked and pressure building up in the chamber, all vents opened and clamps unclamped.Second rn to verify and troubleshoot, had same issue.Tpn fluid backing up from filter into chamber appearing cloudy.Unable to pull air bubbles out with syringe.Disconnected line to try to run fluid through it, and completely blocked with all clamps opened.Defective iv tubing".

• Brand Name: BD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12471037
• MDR Text Key: 271540670
• Report Number: 9616066-2021-52046
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012264
• UDI-Public: 37613203012264
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20350E
• Device Catalogue Number: 20350E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• 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