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

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

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

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).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 manufacturered 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.

Event Description

As reported by the user facility: detailed inquiry description - customer is experiencing "champagne bubbles" in tubing set for the majority of programmed infusions.She also menitoned that they've tried taking the tubing out and flicking it, using alcohol wipes to clean the inside, etc.But have had no luck in finding a solution.She said her pharmacy team told her that this was due to the temperature change of the fluids when taking them out of the refrigerator.The thing that is most bothersome with the pumps is that even after alcohol swabbing the track, flicking out the bubbles, re- setting the tubing, using the anti siphon caps etc, is that once the pump starts going off with the bubble alarm, it continues to do so.Even when the line appears to be without bubbles[?] one of the rns observed the "kinks" in the line where the green key holds it into place may be causing it.Either way, the delay in care is there.Im not sure what other information to provide.I was mostly hoping you guys at b.Braun had some insight or tips/ tricks to make the functionality better.We spend so much time "flicking" the bubbles.Even our patients are like "wow is this normal?".Some even get frustrated by the amount of time if can add to their infusion time.

• 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 REPUBLIC 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: 18397720
• MDR Text Key: 331708027
• Report Number: 2523676-2023-00862
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/27/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1