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

Model Number 2C8750

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Respiratory Arrest (4461)

Event Date 06/20/2023

Event Type  Injury  

Event Description

Breakage at y-port during blood transfusion resulting in disruption of closed system.Partially completed blood product/unit disconnected and re-spiked/attached to the other functional port of the y.Pressure bag and warmer was used as well.Air noted to be entrapped at the y-juncture of the tubing, through the warmer and beyond the air trap, all the way to the patient's central access.Attempts made to remove the air when the patient began to decompensate (low bp).Patient arrested.Patient repositioned, cpr initiated and rosc (return of spontaneous circulation) achieved.

• Brand Name: CLEARLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 17610897
• MDR Text Key: 321836639
• Report Number: 17610897
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2C8750
• Device Catalogue Number: 2C8750
• 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: 08/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 19710 DA
• Patient Sex: Female
• Patient Race: White