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

Catalog Number 2H8519

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that blood backflow was observed while using two (2) clearlink system continu-flo solution sets.At the start of the infusion on an infusion pump, blood return was observed.The clinician verified that the catheter position was correct and then changed the alleged set with a new set.Again, the blood return was observed while using the second set.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Device manufactured between: september 26, 2018 to september 27, 2018.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 - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8457031
• MDR Text Key: 140429363
• Report Number: 1416980-2019-01613
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048451
• UDI-Public: (01)00085412048451
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 2H8519
• Device Lot Number: R18I25099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1