MAUDE Adverse Event Report: INFUTRONIX, LLC. NIMBUS PUMP; PUMP, INFUSION

Device Problems Disconnection (1171); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

The 16 nimbus pain pump failures over past 6 months.Either system error comes up on pump and no longer works, or tubing falls out from pump and is no longer usable until patient can get a new pump inserted.Fda safety report id# (b)(4).

• Brand Name: NIMBUS PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): INFUTRONIX, LLC.
• MDR Report Key: 15807048
• MDR Text Key: 303950076
• Report Number: MW5113323
• Device Sequence Number: 11
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/14/2022
• 16 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other