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

Catalog Number JC8386

Device Problems Partial Blockage (1065); Crack (1135); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified baxter pump displayed an "occlusion" alarm while being used with a clearlink system continu-flo solution set.It was further reported that when trying to irrigate the tubing with sodium chloride (nacl) for five (5) minutes there was no success.This issue was identified during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additionally, the customer tried to remove the male luer with sterile pliers but was not successful.The male luer was separated (tip broke off) and was left attached to the picc (peripherally inserted central catheter) line.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H10: the actual sample was received for evaluation.A visual inspection was performed using the naked eye which revealed a crack in the top component of the luer lock.Functional testing was performed by priming the set and no issues were noted.Additional functional testing was performed including pressure and clear passage tests; no observed blockage or leaks.The reported unsuccessful irrigation condition was not verified, however the broken tip (male luer) was verified.The cause of the broken tip (male luer) could not be determined.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 CORPORATION; deerfield IL
• MDR Report Key: 9371740
• MDR Text Key: 168671653
• Report Number: 1416980-2019-06525
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412152691
• UDI-Public: (01)00085412152691
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: JC8386
• Device Lot Number: DR19F25045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BAXTER PUMP (UNSPECIFIED); PICC LINE; SODIUM CHLORIDE; STERILE PLIERS