MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2R8401

Device Problems Improper Flow or Infusion (2954); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event occurred on an unspecified date in (b)(6) 2020.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a baxter infusion pump presented "air and upstream occlusion" alarms while being used with a clearlink system non-dehp solution set.This occurred during administration of medication in a 250ml bag of 0.9% sodium chloride.It was further reported that the setup included a non baxter device connected to the bag, the solution set, and a one-link non-dehp y-type microbore catheter extension set.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK LUER ACTIVATED VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9694447
• MDR Text Key: 178593061
• Report Number: 1416980-2020-00565
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K180739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2R8401
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.9% SODIUM CHLORIDE 250ML BAG; BAXTER INFUSION PUMP; EQUASHIELD; HERCEPTIN; 0.9% SODIUM CHLORIDE 250ML BAG; BAXTER INFUSION PUMP; EQUASHIELD; HERCEPTIN