MAUDE Adverse Event Report: LEVENTON S.A.U. DOSI-FUSER; PUMP, INFUSION, ELASTOMERIC

Device Problem Failure to Infuse (2340)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

Today we had a malfunction incident with the dosi-fuser.The patient was sent home with the dosi-fuser on wednesday ((b)(6) 2021), when he came back today for disconnect ((b)(6) 2021), the pump didn't infuse any of the medication.The patient refused to be re-treated with a second pump due to work related issues.The clinical team was aware.Fda safety report id# (b)(4).

• Brand Name: DOSI-FUSER
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): LEVENTON S.A.U.
• MDR Report Key: 11506110
• MDR Text Key: 240787758
• Report Number: MW5100038
• Device Sequence Number: 1
• Product Code: MEB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/12/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1