MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number 2C8750

Device Problems Break (1069); Disconnection (1171)

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

Event Date 06/20/2023

Event Type  Injury  

Event Description

It was reported that a clearlink system y-type blood/solution set ¿broke at the y-port¿ during a blood transfusion resulting in a disruption of a closed system.An infusion pump was not used for the transfusion.It was reported that the partially completed blood product/unit was disconnected and re-spiked/attached to the other functional port of the set.A pressure bag and a warmer were also used.Air was 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 were made to remove the air when the patient began to decompensate (low blood pressure), and the patient "arrested" (cardiac arrest).The patient was repositioned, cpr initiated, and rosc (return of spontaneous circulation) achieved.At the time of this report, the patient had recovered from the event and was discharged home in a stable condition.

Manufacturer Narrative

F2: uf / importer report number (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17785235
• MDR Text Key: 323876121
• Report Number: 1416980-2023-04770
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

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: Health Professional
• Device Catalogue Number: 2C8750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRESSURE BAG; WARMER
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female