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

Catalog Number 2C8541

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was backflow during use of a clearlink continu-flo solution set.This occurred during infusion of 5% dextrose/ 0.15% sodium chloride solution in the primary bag, and methotrexate in the secondary bag.The reporter stated that the yellow methotrexate was backflowing into the primary bag in addition to flowing through the patient line.As a result, the patient needed to receive an extra 400ml of fluid to complete the entire dose of methotrexate and the infusion took 4 hours longer than anticipated due to patient size and corresponding fluid rate.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: the device was manufactured (b)(4) 2018 - (b)(4) 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 DUO-VENT 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: 7752834
• MDR Text Key: 116153940
• Report Number: 1416980-2018-04889
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412071107
• UDI-Public: (01)00085412071107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2023
• Device Catalogue Number: 2C8541
• Device Lot Number: R18D04095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2018
• 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
• Treatment: 5% DEXTROSE/0.15% SODIUM CHLORIDE SOLUTION; METHOTREXATE