MAUDE Adverse Event Report: ST PAUL MEDFUSION 4000 SYRINGE INFUSION PUMP

Model Number 4000

Device Problems Device Alarm System (1012); Failure to Cycle (1142); Display Difficult to Read (1181)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received indicating that the pump would not boot, there was a line across the screen and it exhibited a constant alarm.It is unknown if there was any patient involvement or adverse effects.

Manufacturer Narrative

Additional information was received, indicating there was no patient injury.(updated h6 event, problem patient code).Device evaluation: one device was returned for analysis in used condition.Visual inspection showed, a non-original equipment manufacturer case and super capacitor on the main board, the bottom case was cracked by the l-bracket and right plunger case.And the plunger case seal was missing.During functional testing, the reported issue was not duplicated.However, the investigation determined that a possible, but unconfirmed, cause of the reported issue was the non-original equipment manufacturer super capacitor.A manufacturing dhr review was not performed, because the results of the complaint investigation do not indicate, a problem with the manufacture of the device.

• Brand Name: MEDFUSION 4000 SYRINGE INFUSION PUMP
• Type of Device: INFUSION 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: jim vegel ; 6000 nathan lane north; carter; minneapolis, MN 55442
• MDR Report Key: 14196817
• MDR Text Key: 290047978
• Report Number: 3012307300-2022-06948
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586040818
• UDI-Public: 10610586040818
• 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,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4000
• Device Catalogue Number: 4000-0101-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1