MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2H8486

Device Problem Failure to Prime (1492)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two (2) units of clearlink system non-dehp solution sets would not prime past the filter.This issue was identified during priming with a parenteral nutrition product.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: two (2) samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed in both samples including pressure and clear passage under water testing were performed and the filters would not able to prime.The reported condition was verified.The cause of the condition was not 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 SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9521951
• MDR Text Key: 172837287
• Report Number: 1416980-2019-07165
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412074764
• UDI-Public: (01)00085412074764
• Combination Product (y/n): N
• PMA/PMN Number: K952074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2H8486
• Device Lot Number: R18G05079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1