MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number 2N3350

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received and is currently awaiting evaluation completion.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported an unspecified quantity of non-dehp micro-volume extension sets leaked.It was further reported the ¿filter was leaking¿.The event occurred during an unknown process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

B5: upon further due diligence, it was reported the event occurred during patient use.D9 corrected information: the device was received on 24feb2021; not on 09feb2021 as previously reported.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.During functional inspection, including pressure and clear passage testing, no blockage was noted.However, during pressure testing a leak was observed in the air vent of the filter.The reported condition was verified.The cause of the condition could not be determined.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to h6.Additional information for h10: based on further investigation, the most probable cause was determined to be related to the end user/methods exceeding the product pressure specifications of 45psi.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11311701
• MDR Text Key: 232454729
• Report Number: 1416980-2021-00540
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): Y
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1