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

Model Number 4000

Device Problems Device Alarm System (1012); Image Display Error/Artifact (1304)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: date of event is unknown.No information received to date.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 information becomes available.

Event Description

It was reported that there is a travel course error.No additional information.

Manufacturer Narrative

One device was received for evaluation.Visual inspection found the tamper seal was broken, a cracked top case, missing battery, and damaged plunger case.The device's event history log was reviewed for evidence of the reported problem and found, a travel course error.To conduct functional testing an occlusion test was performed.Upon testing, the reported problem was duplicated.It was determined that clutch halves were determined to be the root cause.The clutch halves were replaced as they were over nine years old.The service history review identified an indication that the complaint was related to a service of the device outside of the review period.

• Brand Name: MEDFUSION 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: 17777970
• MDR Text Key: 323801801
• Report Number: 3012307300-2023-09117
• Device Sequence Number: 1
• Product Code: FRN
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000-0101-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1