MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE

Model Number 4000

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical syringe infusion pumps|medfusion 4000 pumps complaint of force sensor test error was revealed in the event log.The event was duplicated during power up process and found to be unable to calibrate during test error.This was isolated to a short electrical circuit, which was caused by main board, force sensor, plunger cable and plunger board are no operating as intended due to the electrical short.Action was taken to replace the main board, force sensor, plunger cable and plunger board.The physical condition of device revealed a crack on the bottom case.Device then passed all functional testing.

Event Description

Information received a smiths medial medfusion syringe pump 4000 alarmed force sensor failure.No patient adverse events reported as was discovered during testing in the event log.

• Brand Name: MEDFUSION
• Type of Device: SYRINGE
• 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: 11405293
• MDR Text Key: 234467216
• Report Number: 3012307300-2021-01694
• 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: 03/03/2021

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: 02/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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