MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. MEDFUSION; ACCESSORIES, PUMP, INFUSION

Model Number 4000

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2020

Event Type  malfunction  

Event Description

Patient had narcan ordered to infuse at a rate of 2.79ml/hr via syringe pump.After approximately 33 minutes, the syringe pump alarmed that the syringe was empty.The narcan 50ml had infused to the patient.Patient's vital signs were stable.Advanced practice registered nurses (aprn) notified.Pump was changed.Pump was programmed correctly, as verified by charge rn and bedside rn.Pump was removed from service.Patient and family aware of incident - no patient harm occurred.Patient was given additional bolus of morphine to cover for pain control, as a result of narcan infusion.Sent to smith's medical for their evaluation and repair.

• Brand Name: MEDFUSION
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 12083588
• MDR Text Key: 258962039
• Report Number: 12083588
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4000
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1