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 Material Discolored (1170)

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

Event Date 10/07/2022

Event Type  malfunction  

Event Description

Nurse was preparing to administer blood and observed that the newly opened package of blood tubing had caps/spikes that looked cloudy/dirty and the drip chamber appeared to be "scuffed." the nurse opened six additional tubing packs from two different lots, and they all appeared similar (cloudy/dirty caps/spikes and some chambers looked almost cracked.This issue was noticed before patient connection and so there was no harm to a patient.The nurse examined a total of 7 sets of tubing from two lot numbers that appeared cloudy.The nurse used single spike tubing to administer the blood.Nurse sent email directly to baxter to report her findings.Follow up: manager contacted a representative at baxter and explained what the nurse had encountered with the cloudy spikes/chambers.The manager asked for any insight they could share about using sets that have this issue.The representative shared information that this product is not made with natural rubber latex.Set discoloration does not affect safety or functionality.The nurse manager is unable to find this statement printed in a visible area on the packaging.Baxter may consider including this statement where the nurse will notice it, directly on the product packaging.

• 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: 15671500
• MDR Text Key: 302401567
• Report Number: 15671500
• 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: 10/18/2022,10/14/2022

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; DR22F24093
• Was Device Available for Evaluation?: Yes
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1