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

Catalog Number 2N3350

Device Problem Disconnection (1171)

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 a non-dehp micro-volume extension set disconnected.It was further reported the patient was in the process of being transferred from the bed and the nurse observed the line was disconnected from ¿3 way manifold hep 1:1 was infusing in 50 ml syringe at rate of 1 ml/hour¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

D9 corrected information: the device was received on 24feb2021; not on 09feb2021 as previously reported.H10: a device was received for evaluation; however, it was not the reported device but a non-baxter device instead.The actual 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: 11311568
• MDR Text Key: 232455046
• Report Number: 1416980-2021-00539
• 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
• Treatment: 3 WAY MANIFOLD; HEPARIN (HEP); UNSPECIFIED SYRINGE