MAUDE Adverse Event Report: INFUSOMAT®; SET, ADMINISTRATION, INTRA

Model Number 490105

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: it was reported via medwatch mw5102219, "bbraun y type blood infusion line had two breaks in the line that caused blood to spray.With loss of about 30 ml estimated.When blood transfusion was started.I witnessed part of the event, as well as inspected packaging for any obvious external damage or evidence of cutting into packaging.None found." no injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400521977.  no sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.  we will maintain this report for further references and continue to monitor other reports for similar occurrences.  if any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INFUSOMAT®
• Type of Device: SET, ADMINISTRATION, INTRA
• MDR Report Key: 12237624
• MDR Text Key: 264065884
• Report Number: 2523676-2021-00221
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964186165
• UDI-Public: 04046964186165
• Combination Product (y/n): N
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 490105
• Device Catalogue Number: 490105
• Device Lot Number: 0061764003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1