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

Device Problem Air/Gas in Device (4062)

Patient Problems Awareness during Anaesthesia (1707); Low Oxygen Saturation (2477)

Event Date 01/25/2024

Event Type  malfunction  

Event Description

As reported by the user facility: per medwatch (b)(4).Product problem occurring (b)(6) 2024 regarding infusomat pump.Age of device is approx 9mo.Occurred in the critical care until of the hospital.Describe the event or problem: "patient was intubated, increased awakening noted and desatting on monitor.Rn attempting to place propofol on b braun space pump.Tubing primed on pump as per b braun instruction, air bubble alarm continuously noted.Patient was desatting and bucking vent due to the sedation not being able to be started within a reasonable amount of time, requiring prn dose of fentanyl.Tubing that was primed on first pump was moved to an alternate pump which then worked without issue.Patient safety event report placed - this is the second occurrence of the same situation that occurred this week.The previous pump was pulled out of service for biomed inspection.When the situation occurred earlier this week it was not on a drug that was critically time sensitive as this event - a patient safety event was not placed for the situation, only a service request for the pump to be looked at.".

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: 18794109
• MDR Text Key: 337565747
• Report Number: 2523676-2024-00216
• 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: Other,Health Professional,User Facility
• 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?: No
• 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