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

Catalog Number FNC1173

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that two (2) clearlink y-type blood sets experienced an unspecified disconnection issue.These events were discovered during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction made to a1: patient identifier: none (previously unknown).Correction made to b5: the event occurred before patient use.There was no patient involvement.(previously reported as there was no report of patient injury or medical intervention associated with this event).Correction made to b6: relevant test/laboratory data: na (previously ni).Correction made to b7: other relevant history: na (previously ni).Additional information was added to d10, h3 and h6.H10: two (2) devices were received for evaluation.A visual inspection was performed and found that the tubing was separated from the blood chamber.A functional test was not performed for this complaint.The reported condition was verified.The cause of the condition could not be determined.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: 10202494
• MDR Text Key: 196763682
• Report Number: 1416980-2020-03619
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: FNC1173
• Device Lot Number: SR18K12046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1