MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE PUMP

Model Number 4000

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Event Description

Information received per email notification on a smiths medical syringe infusion pumps|medfusion 4000 pumps.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.The patient vital signs were stable after the pump infuse the narcan.

• Brand Name: MEDFUSION
• Type of Device: SYRINGE PUMP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10397515
• MDR Text Key: 202590158
• Report Number: 3012307300-2020-08115
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586043567
• UDI-Public: 10610586043567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1