MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number FNC3220N

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The single-use device was received for evaluation.Visual inspection revealed that a small portion of the tubing was squashed and melted.The pouch provided with the set showed no indication of the set being caught in the pouch seal; the pouch seal was found to be properly sealed.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 1 malfunction events.It was reported that a continu-flo blood/solution set was damaged.It was further reported that the tubing was "squashed" and looked "melted".There was no patient involvement.No additional information is available.

• Brand Name: CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; marsa
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8289862
• MDR Text Key: 134571338
• Report Number: 1416980-2019-00385
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: FNC3220N
• Device Lot Number: 18E11V507
• Date Manufacturer Received: 12/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1