MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE

Model Number 3500

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical syringe infusion pumps|medfusion 3500 pumps.The complaint of occlusion error was confirmed during testing and revealed pressure increase check line alarm.This was isolated to force sensor out of calibration reading 0 pounds.The reading should be 6.45 pounds.Also believed to be normal wear.Action was tkan to replace the recalibrate.Pm testing completed.

Event Description

Information received a smiths medical syringe infusion pumps|medfusion 3500 pumps displayed occlusion error.No patient adverse events reported.

• 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; ramsey; minneapolis, MN 55442
• MDR Report Key: 11829251
• MDR Text Key: 250798209
• Report Number: 3012307300-2021-04377
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586041242
• UDI-Public: 10610586041242
• 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: 05/14/2021

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: 3500
• Device Catalogue Number: 3500-0600-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2015
• 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