MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION 4000 SYRINGE INFUSION PUMP; PUMP, INFUSION

Model Number	4000
Medical Device Problem Codes	Device Alarm System (1012); Loss of Power (1475)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date unknown.H3: device not received by manufacturer.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 or Problem Description
It was reported that the device exhibited a green screen, long beep, then would shut off.It is unknown if there was patient involvement, no adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected data: d4 udi number.No product was returned.The investigation was unable to determine a root cause.If the product is returned this complaint will be reopened for further investigation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: MEDFUSION 4000 SYRINGE INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18449481
• Report Number: 3012307300-2024-00068
• Device Sequence Number: 12654123
• Product Code: FRN
• UDI-Device Identifier: 15019517070996
• UDI-Public: (01)15019517070996(11)220609(21)2076337
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000-0106-231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown