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

Catalog Number	2H8603
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) clearlink system non-dehp extension sets would not prime.The event was further described as ¿the medication fills the filter partially and becomes blocked; the medication will not completely fill filter or flow past filter¿.This issue was identified during priming.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
One (1) actual sample was received for evaluation.A visual inspection was performed and did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including pressure testing and clear passage testing which had unsatisfactory results.The returned sample would not prime.The tubing in the y-site in the downstream part was blocked.The reported condition was verified.The cause of the condition was not determined.The remaining device was not received for evaluation; therefore, a device analysis could not be completed.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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9679296
• Report Number: 1416980-2020-00464
• Device Sequence Number: 19499207
• Product Code: FPA
• UDI-Device Identifier: 00085412046433
• UDI-Public: (01)00085412046433
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K952074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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
• Operator of Device: Other
• Device Catalogue Number: 2H8603
• Device Lot Number: R18H14046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1