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

Catalog Number	2H8519
Medical Device Problem Codes	Failure to Prime (1492); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device manufacturer address (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 prime.It was further reported that the line below the drip chamber was blocked.This issue was identified during priming.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the actual sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including pressure testing and clear passage testing was performed, and it was noted that the device would not prime as the check valve was partially blocked by solvent.The reported condition was verified.The cause of the condition was due to incorrect application of solvent on the check valve and tubing during manufacturing.A nonconformance has been opened to address this issue.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: 10528532
• Report Number: 1416980-2020-05660
• Device Sequence Number: 3056113
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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: R20C23044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1