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

Catalog Number MMC9627S

Device Problem Filling Problem (1233)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a vented pacilitaxel set underinfused infliximab while being used with an evo iq pump.It was further reported that at least 100ml under infused and the volume to be infused was 305 ml.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

H10: the actual device was not available; however, a video of the sample was provided for evaluation.Visual inspection was performed in the video sample which revealed a presence of air bubble in the tubing.The reported under infusion was not verified.The cause of the air in the tubing could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction made to f10/h6: health effect - impact codes: replaced f27 with f26.

• Brand Name: CLEARLINK SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11942412
• MDR Text Key: 254517438
• Report Number: 1416980-2021-03378
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• 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: 07/22/2021

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 Catalogue Number: MMC9627S
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 07/12/2021; 07/12/2021
• Supplement Dates FDA Received: 07/12/2021; 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EVO IQ PUMP; INFLIXIMAB