MAUDE Adverse Event Report: NULL MEDFUSION 3500; SYRINGE INFUSION PUMPS

Catalog Number 3500

Device Problem Failure to Sense (1559)

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

Event Type  malfunction  

Manufacturer Narrative

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 not broken or removed.No physical damage found; a review of the event history log identified force sensor test error.Techs performed power up process, check and test force sensor.It was found that the force sensor test error was found at power up process and force sensor reading at 0.00 lbs.The force reading is 26.54 lbs.And the count is over 1000.The root cause was found to be a combination of the force sensor and plunger cable.It was noted the tech replaced the force sensor and plunger cable.Performed power up process and all functional tests which passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the force sensor failure service warranty was sent in on ro 852593.No patient injury reported.

• Brand Name: MEDFUSION 3500
• Type of Device: SYRINGE INFUSION PUMPS
• Manufacturer (Section G): NULL
• MDR Report Key: 15550479
• MDR Text Key: 306518868
• Report Number: 3012307300-2022-21752
• 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: Health Professional
• 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: 07/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1