MAUDE Adverse Event Report: LEVENTON, SAU DOSI-FUSOR; PUMP, ELASTOMERIC, INFUSION

Model Number 25915-250D2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/22/2014

Event Type  malfunction  

Event Description

Chemo infusor appeared to malfunction as approximately 1/4 of chemo infused after close to 46 hours.Visiting nurse saw patient and called to report all clamps were open and port flushed easily with brisk blood return.Infusor was discontinued at scheduled time.Spouse submitted photos of infusor for evaluation via smart phone.Device was not retrieved from the home due to hazardous drug contents being unfit for physical inspection by the manufacturer.

• Brand Name: DOSI-FUSOR
• Type of Device: PUMP, ELASTOMERIC, INFUSION
• Manufacturer (Section D): LEVENTON, SAU; fda agents; 14500 fm 470; tarpley TX 78883
• MDR Report Key: 4208937
• MDR Text Key: 4963359
• Report Number: 4208937
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 25915-250D2
• Device Catalogue Number: N/A
• Device Lot Number: 14021 1L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY
• Patient Age: 47 YR
• Patient Weight: 81