MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2H8480
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address 1: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of four (4) clearlink duo-vent solution administration sets were leaking with the clamp closed.It was further reported that on closer inspection leaking was found just above the filter.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: four (4) devices were received for evaluation.Visual inspection was performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional testing was completed in all samples including clear passage and pressure testing; and the device performed according to product specifications.Additionally priming test was performed and no issues noted.The reported condition was not verified.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 DUO-VENT SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10629454
• Report Number: 1416980-2020-06183
• Device Sequence Number: 2631145
• Product Code: FPA
• UDI-Device Identifier: 00085412048499
• UDI-Public: (01)00085412048499
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 2H8480
• Device Lot Number: R20D29031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1