MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE PUMP

Model Number 4000

Device Problems Device Alarm System (1012); Failure to Sense (1559)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical smiths medical syringe infusion pumps|medfusion 4000 report of system failure was confirmed upon powering up and reviewed in the event log.This was isolated to unable to upload new configuration from base to top.Action was taken to upload new software configuration.Crack was noted on left lower corner of top case and also right plunger case.Device passed all functional testing.

Event Description

Information received a smiths medical syringe infusion pumps|medfusion 4000 pumps alarmed "system failure." no patient adverse events were reported.

• 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: 11719081
• MDR Text Key: 247208932
• Report Number: 3012307300-2021-03421
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4000
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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