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

Model Number 4000

Device Problem Failure to Cycle (1142)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during a returned order service a system failure occurred.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Operator of device is unknown.No information has been provided to date.

Manufacturer Narrative

While performing a review of the complaint, it was discovered that the file was inadvertently assessed as reportable.The malfunction will not be likely to cause or contribute to death or serious injury and no patient death, serious injury, and there is no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.This complaint file is no longer considered reportable, please disregard any reports associated with it.

• Brand Name: MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP
• Type of Device: PUMP, INFUSION
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16294654
• MDR Text Key: 308782547
• Report Number: 3012307300-2023-00857
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586043567
• UDI-Public: 10610586043567
• 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: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4000
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1