MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION 3500 PUMP; PUMP, INFUSION

Model Number	3500
Medical Device Problem Codes	False Alarm (1013); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.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 had a forced sensor occlusion detector.There was unknown patient involvement, and unknown harm/adverse event was reported.
Additional Manufacturer Narrative
H3: one device was returned for repair in good condition.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.No error in history which relates to customer report.Ran force sensor test and force sensor was out of calibration.Force sensor needed recalibration.No repair needed to fix the problem.Device passed all functional tests.

• Brand Name: MEDFUSION 3500 PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19701428
• Report Number: 3012307300-2024-05874
• Device Sequence Number: 3641802
• Product Code: FRN
• UDI-Device Identifier: 10610586043017
• UDI-Public: (01)10610586043017(11)170428
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 3500
• Device Catalogue Number: 3500-0600-82
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1272-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown