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

Catalog Number	2C8671
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 extension set completely emptied.However, upon further clarification it was determined the user was not "inverting and tapping" the filter when priming.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: the actual device was not available; however, a photograph of the companion sample was provided for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition; and further testing be could not be performed.Therefore, the reported condition could not be verified by sample evaluation.However, the cause of the condition was determined to be a use error on behalf of the end user as it was reported they were not inverting and tapping the filter.The baxter sales representative assisted the customer and advised that per the label instructions it states: use aseptic technique.Attach female adapter (1) to fluid source.Fill, invert, and tap filter (2) to purge air during priming.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 ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8967274
• Report Number: 1416980-2019-04824
• Device Sequence Number: 2521183
• Product Code: FPA
• UDI-Device Identifier: 00085412046334
• UDI-Public: (01)00085412046334
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 2C8671
• Device Lot Number: R19B20029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1