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

Catalog Number 2H8519

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of clearlink system non-dehp continu-flo solution sets overinfused.It was further reported that ¿it was all open and they walked away from the patient and came back to an empty bag¿.This issue was identified during patient infusion with an unspecified solution.There was no patient injury or medical intervention associated with this event.No additional information is available.

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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11333997
• MDR Text Key: 233454619
• Report Number: 1416980-2021-00675
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048451
• UDI-Public: (01)00085412048451
• Combination Product (y/n): Y
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2H8519
• Device Lot Number: R20H31061
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED SOLUTION