MAUDE Adverse Event Report: GRIFOLS DOSI-FUSER 4.7ML; ELASTOMERIC INFUSION PUMP

Catalog Number L25915-250D2

Device Problems Inadequate Instructions for Healthcare Professional (1319); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  Other  

Event Description

We placed 2 separate orders for dosi-fuser elastomeric infusion pumps (product #l25915-250d2) to be used in our ambulatory oncology infusion center.The first shipment was provided directly from the mfr (grifols) and was labeled at 4.7 ml/hr.The second shipment of the same product number came from (b)(4) (distributor / wholesaler) and was labeled at 5.2ml/hr.Both products have the same product number and are in identical packaging with the same color coded label.The only differentiation is the rate is printed on a label attached to the outer packaging and the device.This poses a significant risk for medication administration error.I feel the device labeling should be changed to show clear differentiation and avoid confusion.(b)(6).

• Brand Name: DOSI-FUSER 4.7ML
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): GRIFOLS
• MDR Report Key: 4884318
• MDR Text Key: 18382232
• Report Number: MW5043433
• Device Sequence Number: 1
• Product Code: MEB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• 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?: No
• Device Operator: Other
• Device Catalogue Number: L25915-250D2
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2015
• Patient Sequence Number: 1