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

Catalog Number	2H8486
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
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 a clearlink system non-dehp solution set would not flow.The device was filled with 50g of lipids in 250ml.It was further reported the ¿lipids would not flow through the filter.¿ ¿the check valve was inverted and tapped, the bag was not initially squeezed but after the lipid would stop flowing at the filter the bag would then be squeezed.¿ there was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed and according to specifications.A functional testing was performed including pressure testing and clear passage and no issue noted.Additional priming test was performed which observed that the device would not flow.The reported condition was verified.The cause of the condition is a manufacturing 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 SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORTION; deerfield IL
• MDR Report Key: 9862453
• Report Number: 1416980-2020-01598
• Device Sequence Number: 2874764
• Product Code: FPA
• UDI-Device Identifier: 00085412074764
• UDI-Public: (01)00085412074764
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K952074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 2H8486
• Device Lot Number: R18G05079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/17/2020
• 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: LIPIDS