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

Model Number 3500-500

Device Problem Device Alarm System (1012)

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

Event Type  malfunction  

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.

Event Description

It was reported, the device alarmed for motor driver error.No patient injury was reported.

Manufacturer Narrative

While performing a review of additional information provided by the customer, there was no patient involvement, therefore, no patient death, serious injury, and 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.File (b)(4) is no longer considered reportable, please disregard any reports associated with it.

• Brand Name: MEDFUSION 3500 PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16837303
• MDR Text Key: 314295919
• Report Number: 3012307300-2023-04760
• 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: K040899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

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: Health Professional
• Device Model Number: 3500-500
• Device Catalogue Number: 3500-500
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1