MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER; SET, BLOOD TRANSFUSION

Model Number 2C8750

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

The nurse was preparing to administer blood to a patient.She observed issues with the blood tubing (as reported in previous report) including one that appeared to have cracks in the chamber.The nurse did not use any of the tubing to administer blood to the patient, instead she used a single spiked tubing.

• Brand Name: CLEARLINK Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15671503
• MDR Text Key: 302401374
• Report Number: 15671503
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412046341
• UDI-Public: 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: 10/18/2022

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: Health Professional
• Device Model Number: 2C8750
• Device Catalogue Number: 2C8750
• Device Lot Number: DR22G13116
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1