MAUDE Adverse Event Report: ZEFON INTERNATIONAL INFUSEIT; MANUAL PRESSURE INFUSOR

Model Number ZIT-500

Device Problem Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, zefon received a customer complaint where the customer stated that pressure infusor device used for rapid fluid infusion had lost pressure during use.No patient harm was reported.The subject device was returned for evaluation on (b)(6) 2015 and examination concluded that the device held pressure and no leaks were detected.Based on the device hazard analysis, loss of pressure would result in fluids not being infused at the intended rate (i.E, slower infusion rate, through gravity forces only).The risk of significant injury to the patient in this circumstance has been determined to be very low.On (b)(6) 2015, the findings were discussed with the clinical nurse specialist at the hospital.At this time, zefon became aware that the complainant hospital was using the device for an off label purpose.The device is marketed and labeled as an infusor for rapid fluid infusion, but the hospital was using the device for invasive arterial bp pressure monitoring.This off label use requires the pressure cuff to be inflated and maintained under pressure for longer periods of time than is required for rapid fluid infusion.

Manufacturer Narrative

The manufacturer became aware of the device's off label use on 02/19/2015, after the initial customer complaint on (b)(6) 2015.

• Brand Name: INFUSEIT
• Type of Device: MANUAL PRESSURE INFUSOR
• Manufacturer (Section D): ZEFON INTERNATIONAL; ocala FL
• Manufacturer Contact: 5350 s.w. 1st ln.; ocala, FL 34474 ; 3522918444
• MDR Report Key: 4605792
• MDR Text Key: 20778521
• Report Number: 1052798-2015-00001
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZIT-500
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other