MAUDE Adverse Event Report: ST PAUL MEDFUSION 3500 SYRINGE INFUSION PUMP; PUMP, INFUSION

Model Number 3500-500

Device Problem Device Alarm System (1012)

Patient Problem Balance Problems (4401)

Event Type  Injury  

Event Description

It was reported the motor rate error alarmed.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.Manufacturing device.History record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The device was in good condition with no appearance of any physical damage.Motor rate error was found at event history log.Motor rate error was found during occlusion test.The root cause for the report issue was found to be combination of leadscrew and clutch halves does not operate as intended.The replaced leadscrew and clutch halves also replaced worm coupling for preventive.Performed occlusion test and all functional testing which passed.

• Brand Name: MEDFUSION 3500 SYRINGE INFUSION PUMP
• Type of Device: PUMP, INFUSION
• 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; 707 north 190th plaza; minneapolis, MN 55442
• MDR Report Key: 15551210
• MDR Text Key: 301260897
• Report Number: 3012307300-2022-21877
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586032318
• UDI-Public: 10610586032318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890120
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500-500
• Device Catalogue Number: 3500-500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1