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

Model Number 4000-0105-51

Device Problems No Audible Alarm (1019); Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

It was reported that the pump had a primary speaker fail.No patient injury reported.

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.

Manufacturer Narrative

Device evaluation: both tamper seals were intact.Cracked left plunger case screw post.Primary audible alarm bgnd test observed in event history log.Power up process, audio test, occlusion test were performed and the reported issue could not be duplicated.Adc (analog-to-digital converter) counts were within specification.No repair needed for reported problem since no problem was found.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record (dhr) review was not performed.Service history review identified this device has not been in for service previously.

• Brand Name: MEDFUSION
• 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: 16644390
• MDR Text Key: 312333421
• Report Number: 3012307300-2023-03268
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000-0105-51
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1