MAUDE Adverse Event Report: ST PAUL MEDFUSION; SRYINGE

Model Number 3500

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 3500 pumps.The complaint error system failure primary audible alarm bgnd test was not confirmed during occlusion testing.The error was revealed in the event log.The device was assessed for no external damage, or contamination to interconnect board, or speaker.Glue was intact on inter connect flex cable j9 connector.As preventative measures the speaker and interconnect board was replaced.Summary of additional repairs included: replaced bottom case and ear clip due to cracked, calibrated the device.Device passed all functional testing.

Event Description

Information received a smiths medical pumps|medfusion 3500 pump received "error system failure primary audible alarm bgnd test." no patient involvement or injury.

• Brand Name: MEDFUSION
• Type of Device: SRYINGE
• 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; main dock; minneapolis, MN 55442
• MDR Report Key: 10535943
• MDR Text Key: 207000249
• Report Number: 3012307300-2020-09327
• 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: Other
• Type of Report: Initial
• Report Date: 09/15/2020

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: 3500
• Device Catalogue Number: 3500-0600-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• 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