MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE PUMP

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.The complaint of force sensor error was confirmed in the event log and during testing to duplicate event this revealed force sensor values were out of spec; values were 0= -1.28 lb, 5= 3.13 lb, 15= 12.71 lb.Physical condition of the device revealed, cracked battery door and right plunger case.The event if believed to be caused from force sensor was out of calibration due to normal wear.No visible damage found on force sensor.Action was taken to replace the force sensor and calibrate the device.Other maintenance included: replaced right plunger case due to physical damage, replaced bottom case due to broken seal.Replaced worm gear and motor mount due to preventative action.Replaced cable guard due to missing.Cleaned, greased; calibrated device and performed all functional tests which passed.

Event Description

Information received a smiths medical pumps|medfusion 4000 pumps alarmed force sensor error.No adverse patient involvement, as event occurred during testing.

• 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: 10557078
• MDR Text Key: 207688566
• Report Number: 3012307300-2020-09559
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586040818
• UDI-Public: 10610586040818
• 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: Other
• Type of Report: Initial
• Report Date: 09/18/2020

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: 4000-0101-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2020
• Initial Date FDA Received: 09/18/2020
• 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: Initial
• Patient Sequence Number: 1