MAUDE Adverse Event Report: ST PAUL MEDFUSION; INFUSION PUMP

Model Number 4000-0106-01

Device Problems Insufficient Flow or Under Infusion (2182); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received regarding a medfusion 4000 pump.It was reported that the device stopped running during infusion.It is unknown if there was no patient, or clinician injury associated with this event.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes to the customer's reported problem were found during the device history record (dhr) review.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection showed the pump had a cracked battery door and there was non-original equipment management (oem) battery found.A review of the event history log identified primary audible alarm background (bgnd).During functional testing the reported issue was able to be duplicated.The root cause of the issue could not be determined.A corrective and preventative action has been opened to address the primary audible alarm.Replaced speaker as preventive measure and performed self test/occlusion test.Device will be placed in quarantine due to presence of non-oem battery.

• Brand Name: MEDFUSION
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13274401
• MDR Text Key: 284371692
• Report Number: 3012307300-2022-00951
• Device Sequence Number: 1
• Product Code: FRN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000-0106-01
• Device Catalogue Number: 4000-0106-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1