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 verified and validated in event log and during testing.The physical condition of device revealed the bottom case contaminated by the "l" bracket and damaged and missing seal (lining) on bottom case.Cracked and damaged right plunger case and cracked battery door.Upon visual inspection the device revealed contamination.Upon power up testing the device revealed, steady state reading of the force sensor (with no pressure on it) count 0 and - 1.13 lbs.The cause is believed to be customer induced from damage and contamination.Action was taken to replaced right and left plunger cases and recalibrated.Device passed all functional testing.Other repairs to damage and routine maintenance included: replaced right and left plunger cases and recalibrated.Power up, re-calibrated force sensor and device passed all the functional test.

Event Description

Information received a smiths medical syringe infusion pumps|medfusion 4000 pumps alarmed force sensor error.No 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: 10556892
• MDR Text Key: 207688950
• Report Number: 3012307300-2020-09545
• 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: 08/28/2020
• 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