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

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Missed Dose (2561)

Event Date 04/23/2018

Event Type  malfunction  

Event Description

Patient reported that dosi-fuser was not empty 4 hours past expected end time.Home care nurse removed dosi-fuser and instructed patient to return dosi-fuser to clinic.

Event Description

Patient reported that dosi-fuser was not empty 4 hours past expected end time.Home care nurse removed dosi-fuser and instructed patient to return dosi-fuser to clinic.

• Brand Name: DOSI-FUSER
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): LEVENTON S.A.U.; 14500 fm 470; tarpley TX 78883
• MDR Report Key: 7925830
• MDR Text Key: 122352930
• Report Number: 7925830
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

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 the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2018
• Event Location: Home
• Date Report to Manufacturer: 10/02/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/09/2018
• Patient Sequence Number: 1
• Patient Age: 29930 DA