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

Catalog Number	2H8537
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
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 there was backflow flow through a clearlink system non-dehp continu-flo solution set that was connected to an unspecified access secondary set.It was further reported that within 15 minutes of the start of the medication, the secondary set which contains a bag of non-cytotoxic medication pulled into the clearlink system non-dehp continu-flo solution set.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 to h4 and h6.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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: 10098638
• Report Number: 1416980-2020-02985
• Device Sequence Number: 16996052
• Product Code: FPA
• UDI-Device Identifier: 00085412080901
• UDI-Public: (01)00085412080901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: 2H8537
• Device Lot Number: R20A07041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/24/2020
• 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: UNSPECIFIED ACCESS SECONDARY SET; VIAFLEX IV