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

Model Number 4000

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 05/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that a smiths medical medfusion 4000 syringe infusion pump over delivered narcan.It was reported that the pump was programmed to deliver at a rate of 2.79ml/hr; however, after approximately thirty-three (33) minutes the pump alarmed that the syringe was empty.Per reporter 50ml had infused.It was reported that the pump was programmed correctly and was verified by a charge registered nurse as well as a bedside registered nurse.Subsequently the pump was changed and patient received an additional dose of morphine for pain control as a result of the narcan infusion.Patient's vital signs reported as stable and it was reported there was no harm to patient.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product was returned by the customer.As a result, a complaint investigation / product evaluation and problem confirmation cannot be performed.

Event Description

Additional information received via email date of event confirmed (b)(6) 2021 at 13:15pm- the reported event occurred while in use with the patient.The event did not cause or contribute to the patient or clinical injury.Outcome of the event resolved and no concomitant medical products mentioned and the patient did not receive medical treatment.

Event Description

Additional information received via email date of event confirmed (b)(6) 2021 at 13:15pm- the reported event occurred while in use with the patient.The event did not cause or contribute to the patient or clinical injury.Outcome of the event resolved and no concomitant medical products mentioned and the patient did not receive medical treatment.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product was returned by the customer.As a result, a complaint investigation / product evaluation and problem confirmation cannot be performed.

• Brand Name: MEDFUSION 4000 SYRINGE INFUSION PUMP
• Type of Device: INFUSION PUMP
• 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: david halverson ; 6000 nathan lane north; suite 103; minneapolis, MN 55442
• MDR Report Key: 12277841
• MDR Text Key: 265126929
• Report Number: 3012307300-2021-08070
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586043567
• UDI-Public: 10610586043567
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1000060000-2021-8021
• Patient Sequence Number: 1
• Patient Sex: Male