MAUDE Adverse Event Report: ST PAUL MEDFUSION 3500; SYRINGE INFUSION PUMPS

Catalog Number 3500

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The tamper seal was broken and plunger assembly (fluid ingression) was removed and sent in by customer, counterfeit top case and bottom case.Battery is missing.A review of the event history log identified force sensor test error.A visual inspection was performed.Plunger assembly (fluid ingression) was removed and sent in with pump by customer.The fluid ingression was caused by counterfeit top case and the root cause was confirmed as customer damaged.Th techs replaced the whole plunger assembly, plunger tube and plunger cable.Performed power up process and all functional testing which passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product information has been provided to date.

Event Description

It was reported that liquid spilled on device.No patient injury reported.

• Brand Name: MEDFUSION 3500
• Type of Device: SYRINGE INFUSION PUMPS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 100 michigan street north east; minneapolis, MN 55442
• MDR Report Key: 15550569
• MDR Text Key: 306693013
• Report Number: 3012307300-2022-21762
• Device Sequence Number: 1
• Product Code: PHO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1