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

Catalog Number 2H8486

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

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 an unspecified number of clearlink system continu-flo solution sets underinfused during a chemotherapy treatment with an infusion pump and a closed system drug transfer device (non-baxter).It was further reported that it seemed to be taking an excessively long time to infuse the 30 minute infusion.The medication was mixed in 600 ml and was to run at 300 mls/hour and it took two hours and 50 minutes to completely infuse the whole bag.This issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information received: update brand name (remove clearlink duo-vent continu-flo solution set), update catalogue # (remove 2c8541), add lot # (initially unknown), update pma/510k # (remove k961225), the actual device was not available; however, a photograph of the sample package was provided for evaluation.The photograph revealed a different product code than initially reported and contained a lot number (initially unknown).A visual inspection was performed to the picture using the naked eye, however, it was not possible to identify the reported issue via the photograph.Due to the nature of the sample no functional testing could be performed.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 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: 9599150
• MDR Text Key: 175376700
• Report Number: 1416980-2020-00061
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952074
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2H8486
• Device Lot Number: R18G04064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: No
• 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