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

Catalog Number 2C8593

Device Problems Backflow (1064); Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2020

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 there was backflow of blood from the central line while a patient was using a clearlink system continu-flo solution set.The backflow of blood occurred when the patient was laid on their back to reposition.It was further reported that the blood backflowed away from the patient toward the lumen to the intravenous (iv) tubing.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction f10/h6: device codes: (remove 1522 and replace with 1064).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 ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9688033
• MDR Text Key: 178539346
• Report Number: 1416980-2020-00524
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412071664
• UDI-Public: (01)00085412071664
• Combination Product (y/n): N
• PMA/PMN Number: K153158
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8593
• Device Lot Number: R19E30112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1