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

Model Number	3500
Medical Device Problem Code	Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device's calibration slug does not line up properly with the force sensor.Per reporter it needs to be slightly lifted to make contact.The position readings are affected.There was unknown patient involvement.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection noted the plunger tube to be bent.The reported problem was verified.The plunger tube was replaced.The device then passed all functional tests.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: MEDFUSION 4000 PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21312965
• Report Number: 3012307300-2025-01511
• Device Sequence Number: 8243975
• Product Code: FRN
• UDI-Device Identifier: 10610586032318
• UDI-Public: (01)10610586032318(11)110602
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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: 3500-500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2011
• 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