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

Catalog Number	2H8486
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two clearlink non-dehp solution sets were unable to be primed.The event occurred during priming with unspecified lipids, described as "50 grams in 250 mls".The reporter stated that the check valve was inverted and tapped, the bag was not initially squeezed but after the lipid stopped flowing at the filter the bag was then squeezed.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: two (2) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.During the decontamination of the sets, lipids were observed dried and blocking the filter.The samples were decontaminated.Functional testing including pressure and clear passage under water testing was performed, and the devices were found to operate per specification.The sets were then primed.During priming, no flow was observed through the filter of one device, and the other device primed without any difficulty.The reported condition was verified for one device.The cause of the condition was not determined.The reported condition was not verified for the second device.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: 9878779
• Report Number: 1416980-2020-01711
• Device Sequence Number: 3419100
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 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: 02/28/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1