MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET, ADMINISTRATION, INTRA

Model Number 490105

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).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.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this 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.

Event Description

As reported by the user facility: detailed inquiry description: ccu nurse was infusing blood and her pump alarmed vtbi but when she entered the room, she noted what she thought was approximately 50-60cc of blood still in the bag as well as the saline to be slightly blood tinged.She removed the blood tubing from the pump to infuse to gravity and noted that the clamps on the saline and on the blood could not be completely closed.She noted drops in the drip chamber despite both roller clamps being closed.She was only able to stop the infusion by closing the third roller clamp closest to the patient.She stated her saline and blood had mixed together because the roller clamps were not working.This caused the infusion to run longer.A patient event did not occur as the blood was infused within the 4 hour window.No injury reported.

Manufacturer Narrative

This report is being submitted as a correction for b.Braun medical internal report number (b)(4).Please note a batch number was not provided review of the of the discrepancy management system (dsms) database was unable to be performed.

• Brand Name: INFUSOMAT®
• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16336482
• MDR Text Key: 309186533
• Report Number: 2523676-2023-00034
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964186165
• UDI-Public: (01)04046964186165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 490105
• Device Catalogue Number: 490105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male