MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK SYSTEM, Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER; SET, BLOOD TRANSFUSION

Model Number 2C8750

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 10/19/2018

Event Type  malfunction  

Event Description

Patient receiving blood transfusion.About 1.5 hours into blood transfusion, treating rn noticed the blood tubing/blood tubing filter chamber was completely full (it hadn't been) and blood appeared to be leaking down the side of the filter chamber.Transfusion was stopped, charge nurse in to assess situation.Could not tell where blood was leaking from, but it was determined that the iv tubing was no longer a closed system (had been compromised) and transfusion was terminated.Appeared to be a blood tubing malfunction.Lot # on blood tubing is lot (10)dr18b10021.Tubing is baxter clearlink system, y-type blood/solution set with standard blood filter.

• Brand Name: CLEARLINK SYSTEM, Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 8008649
• MDR Text Key: 125149713
• Report Number: 8008649
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412046341
• UDI-Public: (01)00085412046341
• 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: 10/21/2018

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: No Information
• Device Model Number: 2C8750
• Device Catalogue Number: 2C8750
• Device Lot Number: (10)DR18B10021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31390 DA