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

Catalog Number 2H8603

Device Problems Partial Blockage (1065); No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the filters of two clearlink system non-dehp extension sets were blocked in which the medication (unspecified) could not flow past the filter.This issue was noted during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: two (2) actual samples were received for evaluation.Visual inspection was performed and did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed according to specifications.Functional testing including pressure testing and clear passage testing was performed and found that the white port of the filter would not flow only in the first sample.No issues were observed in the other sample.Additional evaluation was performed by priming the sets and the results were satisfactory.The reported condition was verified only in the first sample.The cause of the condition was due to an excess of solvent applied during the manufacturing process.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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9642947
• MDR Text Key: 176824889
• Report Number: 1416980-2020-00265
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412046433
• UDI-Public: (01)00085412046433
• Combination Product (y/n): N
• PMA/PMN Number: K952074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2H8603
• Device Lot Number: R19D29034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1