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

Device Problem Air/Gas in Device (4062)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Event Description

As reported by the user facility: brief inquiry description: excessive microbubbles in tubing set making pump alarm for air in line repeatedly.Detailed inquiry description: "we've been having a repeated problem in the icus with running any refrigerated drips.For some reason, when they're hung, an excessive amount of microbubbles is forming in the tubing, creating incessant alarms, medication waste, delays in patients receiving appropriate dosing in a timely manner, etc.We have tried taking meds out of the omnicell an hour early to attempt to acclimate the temperature, tried back-priming.Just about every troubleshooting method you could think of." "the fentanyl, precedex and levo gtts are just as bad, and even worse if they need to be hung immediately out of the fridge.We had a patient on icu-1 become profoundly hemodynamically unstable again last week because of these bubbles." description of the patient event unable to infuse critical drips due to excessive air in line alarms in turn the patient became critically hemodynamically unstable.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400629632.No sample and/or lot number was provided for evaluation; however, b.Braun has initiated a voluntary medical device correction 2523676-9/26/23-004-c for multiple batches of infusomat® pump sets manufactured between 01 january 2022 - 17 august 2023.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.

• 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: 18253632
• MDR Text Key: 329550559
• Report Number: 2523676-2023-00781
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention