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

Model Number 4000-0106-01

Device Problems No Audible Alarm (1019); Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that the pump has a speaker error and bottom case is cracked.No patient injury reported.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Device evaluated, visual inspection performed and found scratched keypad, cracked battery door and right plunger case.Unable to view event history log due to blank screen with constant alarm.The reported issue was duplicated found blank screen with constant alarm at power up.Found cracked battery door, but there was no cracks or damage to the bottom case.The cause of the reported issue was due to incomplete update process by customer.Impact, customer damaged.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a review was not performed.Service history review identified this device has not been in for service previously.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16669480
• MDR Text Key: 313023695
• Report Number: 3012307300-2023-03447
• 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
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• 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: 03/22/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1