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

Model Number 4000-0105-51

Device Problems Device Alarm System (1012); Alarm Not Visible (1022); Data Problem (3196)

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

Event Type  malfunction  

Event Description

It was reported the pump is not able to properly keep the log history.Customer stated that the pump had an audible alarm issue 2 times, but the alarm logs are not showing this error.It was also mentioned that the year of 1980 was displayed in the alarm logs.No patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause for the audible alarms not being logged into the event history log and a date of 1980 being displayed is due to the main board not operating as intended; however, this cannot be confirmed as no product was returned for investigation.The service history review identified an indication that the complaint was related to a service of the device outside of the review period.B3: unknown.

• Brand Name: MEDFUSION 4000 WIRELESS 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: 16836388
• MDR Text Key: 314411658
• Report Number: 3012307300-2023-04751
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4000-0105-51
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1