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

Catalog Number 2C8750

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the spike of clearlink system y-type blood/solution set broke which subsequently leaked.The event occurred when the nurse was spiking the bag for a blood transfusion.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, f2, g3: report source, h3, h4 and h6.F2: the user facility submitted a medwatch report for this event: mw5098505.H10: the device was received for evaluation contaminated with blood.Visual inspection performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specification.Due to the nature of the returned sample, no additional testing could be performed.The reported condition was not verified.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: 11173698
• MDR Text Key: 229529351
• Report Number: 1416980-2020-08506
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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: DR20J20020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1