MAUDE Adverse Event Report: LEVENTON DOSIFUSER; ELASTOMERIC INFUSION DEVICE

Model Number L25915-250D2

Device Problems Device Markings/Labelling Problem (2911); Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

Our ambulatory oncology infusion pharmacy ordered dosifuser (mfg leventon - (b)(4)) elastomeric infusion pump product (l25915-250d2) and have received pumps with 2 different infusion rates.One was rated at 4.7 ml/hr and the other was 5.2 ml/hr- both labeled with the same packaging, product number, and color coded label.I will attach a photo if this system allows.

• Brand Name: DOSIFUSER
• Type of Device: ELASTOMERIC INFUSION DEVICE
• Manufacturer (Section D): LEVENTON; barcelona ; SP
• MDR Report Key: 4730538
• MDR Text Key: 5581144
• Report Number: MW5042305
• Device Sequence Number: 2
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 04/17/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: L25915-250D2
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2015
• Patient Sequence Number: 1