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

Catalog Number 2C8537

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported an unspecified access set back flowed.It was further reported that the event occurred during patient infusion.A clearlink secondary set was connected to a secondary administration bag filled with methylene dye in 100ml 5% dextrose and ¿through the backcheck value¿ which is connected to a 1000ml viaflex bag.¿to prevent to medication from back flowing into the primary bag we clamped the primary line once this issue was discovered¿.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added.Additional information/correction:catalog number, manufacturer,pma/510k #.Address: (b)(4).The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure testing and clear passage under water testing were performed with no issues noted.The set was primed, and backflow functional testing was performed.The device primed normally and worked per specification with no backflow noted.The reported condition was not verified.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
• 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: 9781620
• MDR Text Key: 181817560
• Report Number: 1416980-2020-01144
• Device Sequence Number: 1
• Product Code: FPA
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8537
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1000ML 0.9% SODIUM CHLORIDE; 1000ML VIAFLEX BAG; 5% 100ML IV MINI BAG; 5% DEXTROSE 100 ML; CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET; METHYLENE BLUE