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

Device Problems Device Alarm System (1012); Air/Gas in Device (4062)

Patient Problems Awareness during Anaesthesia (1707); Low Blood Pressure/ Hypotension (1914)

Event Date 02/12/2024

Event Type  malfunction  

Event Description

As reported by the user facility: brief inquiry description: equipment medical device alarm issues.Detailed inquiry description: "rn was assisting with removal of pa catheter.During just in time in-service, she noticed that precedex was alarming stating it had air bubbles.In an attempt to correct it we saw huge air bubbles in the iv tubing.We flicked the air, aspirated etc.But after that, the pump still said it had air even though we can't see it anymore (we had to ok and restart it, but it was still doing it so we had to reflick it and go through the trouble shooting process again.The intubated patient started getting restless, so we decided to prime a brand-new tubing and spike a new bag.We had to hold down the patient and restart epi drip b/c the maps are on the 40-50's and we can't go up on the precedex drip due to low maps.While this was happening the dobutamine drip started alarming that it had air but upon examing it we did not see any visible air bubbles so we decided to change the iv tubing as well." please note this was obtained from the organization.Iv tubing obtained from nurse manager and sequestered for diego to ship.

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.

• 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: 18794252
• MDR Text Key: 336792554
• Report Number: 2523676-2024-00224
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• 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