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

Model Number	4000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there are parts moving inside the unit.Patient involvement unknown.
Additional Manufacturer Narrative
Other text: b3.Date of event is unknown.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 reportable information becomes available.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection found the bottom case tamper seal to be broken, and a damaged top case.Review of the device's event history log was unable to be done due to the log being cleared.Functional testing was conducted.Upon review, the reported problem was duplicated.It was determined that foreign pieces to the device were the root cause.The broken pieces were removed from the device.The service history review identified an indication that the complaint was related to a service of the device outside of the review period.Health effects updated,.

• Brand Name: MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17847079
• Report Number: 3012307300-2023-09443
• Device Sequence Number: 19930227
• Product Code: FRN
• UDI-Device Identifier: 15019517154313
• UDI-Public: 15019517154313
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: 4000-0106-01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown