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

Catalog Number 2C8519

Device Problem Filling Problem (1233)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The event occurred on an unspecified date between (b)(6) 2019 and (b)(6) 2019.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during flow rate testing of a spectrum pump, it was observed that there was an underinfusion while using a clearlink system continu-flo solution set.During testing via a spectrum pump, the infusion was ¿within +/- 5% of the intended flow rate.¿ the testing was performed in a laboratory setting with no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing including, dimensional, pressure, stability and clear passage under water testing was all performed, and the device was found to be within the product specification range.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 CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9676826
• MDR Text Key: 178012138
• Report Number: 1416980-2020-00442
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048994
• UDI-Public: (01)00085412048994
• Combination Product (y/n): N
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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
• Device Operator: Other
• Device Catalogue Number: 2C8519
• Device Lot Number: R19F25045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2020
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1