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

Catalog Number	2H8519
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2020
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 a clearlink system non-dehp continu-flo solution set would not flow.It was further reported that the solution would only reached the chamber.This was identified during use.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h3, h4, and h6.H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed that the check valve was not assembled according to product specifications.Functional testing was performed including pressure testing and clear passage testing and the results were not satisfactory as there was a no flow observed due to the check valve not being assembled to specification.The reported condition was verified.The cause of the condition is manufacturing related.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 CONTINU-FLO SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10896538
• Report Number: 1416980-2020-07339
• Device Sequence Number: 3254329
• Product Code: FPA
• UDI-Device Identifier: 00085412048451
• UDI-Public: (01)00085412048451
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K961225
• 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): 12/28/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2H8519
• Device Lot Number: R20F09053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SOLUTION