MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE PUMP

Model Number 4000

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information received a smiths medical medfusion 4000 pumps was return: received device back from repair with force sensor error (recently serviced on ro 1075311).No adverse patient events reported.

• 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; c/o community hospital; minneapolis, MN 55442
• MDR Report Key: 10432807
• MDR Text Key: 203721881
• Report Number: 3012307300-2020-08357
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 15019517069624
• UDI-Public: 15019517069624
• 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: 08/20/2020

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: 4000-0106-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• 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