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

Catalog Number 2N3350

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported two (2) non-dehp micro-volume extension sets appeared cracked and subsequently leaked.During a prn fentanyl infusion, drops were observed originating from the filter.The leak was noted to be coming from a cracked filter on the line.When the line was replaced, the nurse attempted to re-administer the fentanyl dose and the filter was again noted to be leaking from the filter.The line was again replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: a2, d4, h4 and h6 a2: age of patient: the patient's age was not reported; however, it was reported the patient was an "infant".D4:lot number: the lot number was initially reported as unknown; however, the reported lot number is dr20h20049.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

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: 11234221
• MDR Text Key: 232159287
• Report Number: 1416980-2021-00190
• 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: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3350
• Device Lot Number: DR20H20049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FENTANYL