MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B BRAUN INFUSOMAT SPACE PUMP IV SET; PUMP, INFUSION

Lot Number 06842006

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

Was shared approximately a week later however it was reported from nursing leadership that during a tavr procedure, the bbraun infusomat tubing (3 port) came off the cassette of the pump and "became disconnected" or "fell apart".This was taken back by bbraun drug rep on (b)(6) 2022 and he will report to their respective department.

• Brand Name: B BRAUN INFUSOMAT SPACE PUMP IV SET
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16069206
• MDR Text Key: 306425672
• Report Number: MW5114068
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 06842006
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other