MAUDE Adverse Event Report: LEVENTON DOSI-FUSER; PORTABLE ELASTOMERIC INFUSER

Model Number 100ML 2 DAYS 1.9ML/HR

Device Problem Inaccurate Delivery (2339)

Patient Problem Underdose (2542)

Event Date 09/14/2017

Event Type  malfunction  

Event Description

Patient's dosi-fuser (100 ml at 1.9ml/hr for 46 hours) did not deliver patient chemotherapy property.Per pharmacist the patient only received half of the intended dose.Patient's port located in the right upper chest flushed with normal saline without difficulty.

• Brand Name: DOSI-FUSER
• Type of Device: PORTABLE ELASTOMERIC INFUSER
• Manufacturer (Section D): LEVENTON; barcelona ; SP
• MDR Report Key: 6876087
• MDR Text Key: 86755459
• Report Number: MW5072212
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100ML 2 DAYS 1.9ML/HR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR