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

Model Number 4000

Device Problems Degraded (1153); Device Sensing Problem (2917)

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

Event Type  malfunction  

Event Description

T was reported that pump exhibited failure not recognized message and there was damage noted.No patient injury was 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.No information has been provided to date.

Manufacturer Narrative

B5: additional information received on 01-aug-2022 via email and attached to complaint object: this pump was not being used on a patient.Initial reporter name, email, and phone number have been updated.H6: event problem and evaluation codes: updates not required., corrected data: d4: correction: model number: 4000.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The reported problem was not related to any previous repair.Visual inspection found the top case was chipped in the front and the right plunger case broken.There was evidence of the reported problem in the event history log.The reported problem was seen upon inspection as the chip was broken off the plunger printed circuit board and the case damaged.This was due to impact and attributed to improper handling by the customer.For corrective action the plunger pcb and case were both replaced.A manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

• Brand Name: MEDFUSION 4000 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: 14935556
• MDR Text Key: 303258603
• Report Number: 3012307300-2022-12957
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586040818
• UDI-Public: 10610586040818
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4000
• Device Catalogue Number: 4000-0101-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1