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

Catalog Number 2N3350

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported a non-dehp micro-volume extension set leaked.During an unspecified infusion, a leak was observed from an unreported location.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

B5: upon follow up it was reported that during a patient infusion of ¿vasoactive agents¿ with epinephrine the nurse observed a leak at the end of syringe tubing above cap connection to manifold.After the leak was observed, the set was changed, resulting in interruption of the medication.The patient experienced acute hypotension and required ¿resuscitation with epi spritzers, cacl, nahco3 and fluids".At the time of this report, the patient outcome was reported as ¿unable to disclose¿.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: the set was changed.H10: the device was not returned, and the lot number is unknown.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: 11252024
• MDR Text Key: 229367247
• Report Number: 1416980-2021-00257
• 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,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3350
• 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: UNSPECIFIED MEDICATION; UNSPECIFIED MEDICATION
• Patient Outcome(s): Required Intervention