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

Catalog Number 490100

Device Problem Air/Gas in Device (4062)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/22/2024

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: brief inquiry description - repeated ail alarms caused disruption to infusion and patient impact.Detailed inquiry description - narrative from customer- "sorry that the first time reaching out is with a problem, but, icu had a rough night last night, even with the bbraun educator ((b)(6) i believe?) here with them.There was one patient in particular that was having so many air in line issues that they had to eventually have a second pump set up and primed so that when the levophed alarmed they could quickly connect the back up pump instead while they re-primed the first pump.The pts blood pressure kept dropping to dangerous levels all night (40/20s) anytime the med was stopped, requiring them to give 5 phenylephrine sticks which is crazy.They tried a total of 5 different pumps, multiple tubing lines, and different bags and concentrations of the medications but continued to have problems.None of the medications were refrigerated and the bbraun educator was there with them watching them prime and had no advice.We even burped the bags so there was no air and used a syringe to prime the secondary port, and somehow air was still getting in the line.Again, this was levo from our pyxis machine and not refrigerated.This also happened on dayshift yesterday in with a different patient with vasopressin, and aaron the bbraun educator was there helping with no luck either.I know this is an ongoing issue with other sites, and we are trying to look at dose tracker and see if it as frequent as it feels? at (b)(6) they were able to show all the air in line alarms for the past day and what the medication running was, so we are trying to do that and maybe find a pattern? it seems to be levophed and vasopressin, but maybe we are just noticing those ones more because of how dangerous they are when they stop.We are also trying to get the anti-reflux valves from st joes since that seemed to help them.Description of the patient event - ail- levophed administation interrupted due to ail which caused blood pressure drop.Had to receive addition medication to stabilize bp.

• 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: 19040652
• MDR Text Key: 339366391
• Report Number: 2523676-2024-00308
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964186080
• UDI-Public: (01)04046964186080
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 490100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/04/2024
• 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