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

Device Problem Air/Gas in Device (4062)

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

Event Date 03/03/2024

Event Type  malfunction  

Event Description

As reported by the user facility: "pt was in clinic to get her last day of chemo - with 1l ns over 2h then cytoxan and fludarabine.When the l of ns was finished it had run dry.Yesterday when i ran a 1l bolus it didn't run dry but only had maybe 10mls left in the bag.Then i gave cytoxan - pump beeped with air bubble many times, chemo paused and line was taken out of pump and checked - there were very small bubbles in the line that goes through the pump.I flicked them up the line (toward the pt) and placed tubing back in the pump.Started the chemo again.When it beeped the next time it was finished.However, the chemo in the line ended after the pump and close to the phaseal.For the fludarabine, it did beep with air bubbles, i did the same thing and checked the line and restarted.It kept beeping with what i thought was ran dry.When i looked for the chemo in the line, it was up toward the bag of chemo." no injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.Because a lot number was not provided it is not possible to determine if this device met the specifications that applied at the time it was manufactured.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, INTRAVASCULAR
• 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: 19153664
• MDR Text Key: 340748033
• Report Number: 2523676-2024-00388
• 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
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• 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: 03/26/2024
• 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