MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE PUMP

Model Number 4000

Device Problems Excess Flow or Over-Infusion (1311); Failure to Auto Stop (2938); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Event Description

Information received a smiths medical syringe infusion pumps|medfusion 4000 pumps would not follow program.A nurse reported when the pump was supposed to stop giving the medication it never did, the nurse then proceeded to push the stop button and the pump never stop.She had to yank the power cord out from the wall to get the pump to stop infusing the medication.There was no incident patient incident reported as nurse was there to interrupt and stop therapy of unknown medication infused.

Manufacturer Narrative

Other, other text: returned device was received in good physical condition.No evidence of reported problem in event log was found.During the evaluation of the device, analysts were unable to duplicate the reported event.There was no fault found with the returned pump.The key pad was replaced as a preventative measure.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: MEDFUSION
• Type of Device: SYRINGE PUMP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10624288
• MDR Text Key: 209754281
• Report Number: 3012307300-2020-10108
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586043567
• UDI-Public: 10610586043567
• Combination Product (y/n): N
• PMA/PMN Number: K111386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2020
• 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: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1