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

Catalog Number 4C8723

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2022

Event Type  malfunction  

Event Description

It was reported that air bubbles were observed in two (2) clearlink system y-type blood/solution sets.The issue was identified during patient infusion.The tubing was replaced to resolve the issue.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: one (1) actual device was received for evaluation.The other device was not received and therefore, could not be evaluated.Visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specifications.A functional testing was performed including clear passage and pressure testing; and the results were satisfactory.Additional priming was performed at the set and no defect was observed.The reported condition was not verified.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 - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15221926
• MDR Text Key: 301940903
• Report Number: 1416980-2022-04216
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4C8723
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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