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

Catalog Number 2C8750

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system y-type blood/solution set broke at the section between the spike and the tubing.This was identified when a nurse spiked a bag of platelets during setup and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3, h4 and h6.H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed the tubing was separated from the spike.A closer inspection was performed which revealed a lack of solvent applied in the tubing.An additional pull test was performed on the rest of the joints and no issues were noted.The reported condition was verified.The cause of the condition is related to manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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
• MDR Report Key: 10901791
• MDR Text Key: 218206944
• Report Number: 1416980-2020-07368
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412046341
• UDI-Public: (01)00085412046341
• Combination Product (y/n): Y
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8750
• Device Lot Number: DR20G27020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1