MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, BLOOD TRANSFUSION

Model Number 2C8750

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 07/26/2018

Event Type  malfunction  

Event Description

Nurse attached platelets and ns to y type blood/solution set with standard blood filter #2c8750s.Nurse hooked up to iv pump.Nurse noted after starting infusion that platelets were backing up into the ns bag.On inspection the blood administration tubing was missing the clamps that are on normally between each bag and the filter.Verified clamps were supposed to be on tubing by the picture on outside of packaging shows clamps and when compared to tubing in a different package with same number clamps were noted on the tubing.

• Brand Name: CLEARLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 7841783
• MDR Text Key: 119058583
• Report Number: 7841783
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2C8750
• Device Catalogue Number: 2C8750
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA