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

Catalog Number 2C8519

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Event(s) occurred the week of (b)(6) 2018.(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 continu-flo solution sets had the "locking valve" that did not work causing solution to backflow.This was observed during infusion.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 received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specification.Functional tests including pressure, drop size delivery and clear passage under water tests were performed and the results were satisfactory.Additional backflow test was performed with one secondary medication.The set worked according to specification.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 - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8257519
• MDR Text Key: 133377948
• Report Number: 1416980-2019-00135
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048994
• UDI-Public: (01)00085412048994
• 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: 02/12/2019

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 Expiration Date: 07/24/2023
• Device Catalogue Number: 2C8519
• Device Lot Number: R18G24054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 02/10/2019
• Supplement Dates FDA Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2018
• 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