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 complaint of back up audible alarm post system failure was confirmed during testing and revealed in event log.This was as indicated, the mother board needing replacement.Action was taken to replace the mother board.The device overall was in excellent condition.Device passed delivery testing and ready for service.

Event Description

Information received a smiths medical syringe infusion pumps|medfusion 3500 pumps revealed system failure error code, spoke motherboard needs to be replaced.No patient adverse events occurred.

• 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: 11829318
• MDR Text Key: 250800714
• Report Number: 3012307300-2021-04378
• 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: foreign,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

• Date FDA Received: 05/14/2021
• 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
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2020
• 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