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

Model Number 2C8750

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2020

Event Type  malfunction  

Event Description

After 5 minutes of platelets infusing, tubing noted to be leaking at the distal end of the tubing just above the leur lock (lot (10)dr19j15023).Tubing discarded and platelets spiked with new tubing (lot#(10)dr19j15023).Platelets infused and completed without incident.Second bag of platelets spiked, tubing noted to be leaking again at the distal end of the tubing just above the leur lock (lot (10)dr19j15023).Tubing discarded and platelets spiked with new tubing (lot (10)dr19j15023) and second bag of platelets completed without difficulty.Manufacturer response for set, blood transfusion, clearlink (per site reporter).Our materials management team is in contact with the baxter representative and will hand-deliver this tubing to this representative.

• Brand Name: CLEARLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 32650 n. willson blvd wgl-3n; round lake IL 60073
• MDR Report Key: 9670680
• MDR Text Key: 177779030
• Report Number: 9670680
• 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: 01/29/2020,01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• 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: (10)DR19J15023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA