MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK DUO-VENT SECONDARY MEDICATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2H7462

Device Problems Device Displays Incorrect Message (2591); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of clearlink secondary medication sets had collapsed tubing causing upstream occlusion alarms on the infusion pump.It was further reported that on other occasions the roller clamps compressed the tubing and the tubings did not come back to the initial form causing occlusions.This was noted during patient infusions.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual devices were not available; however, a photograph of one (1) sample was provided for evaluation.Visual inspection on the photograph revealed a damaged chamber.No functional test was performed due to the nature of the sample.The reported condition was verified on the one (1) sample through photo inspection.The cause of the condition is related to the material during manufacturing.Additional samples were not returned; therefore a device analysis could not be completed for those samples.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT SECONDARY MEDICATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8438556
• MDR Text Key: 139477950
• Report Number: 1416980-2019-01504
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2H7462
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COLLEAGUE PUMP; PRIMARY SET