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

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Overdose (1988)

Event Date 05/16/2018

Event Type  malfunction  

Event Description

Patient was connected to a dosi-fuser home pump containing fluorouracil on monday.The office received a phone call from a home care rn reporting that the dosi-fuser had completed the entire infusion 24 hours early.The correct infusion period should have been from monday at 1 pm until wednesday at 1 pm.The patient reported that the dosi-fuser completed on tuesday at about 1 pm.

• 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: 7925858
• MDR Text Key: 122353511
• Report Number: 7925858
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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
• Is the Reporter a Health Professional?: Yes
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA