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

Catalog Number 2H8603

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

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 there was no flow of medication through a clearlink system non-dehp extension set.It was further reported that the filter became clogged during lipid administration which causes a delay of the administration.To resolve this issue, the set was replaced, and therapy was continued.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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 specifications.Functional testing including pressure and clear passage tests were performed which revealed no flow in the filter.The priming was performed which revealed no flow in the filter.The reported condition was verified.The cause of the condition was due to a manufacturing issue.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
• MDR Report Key: 12502325
• MDR Text Key: 272508637
• Report Number: 1416980-2021-05801
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412046433
• UDI-Public: (01)00085412046433
• Combination Product (y/n): Y
• PMA/PMN Number: K952074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2H8603
• Device Lot Number: R21D24114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LIPID