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

Model Number	3500
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that this smiths medical medfusion 3500 pump exhibited issue with the plunger sensor, barrel clamp sensor, and shaft making noises when moving around.No patient injury reported.
Additional Manufacturer Narrative
Other text: additional information was received indicating there was no patient involvement; issue found during maintenance.Device evaluation: one smiths medical medfusion 3500 pump was returned for analysis in used condition.Visual inspection showed tamper seals were removed/broken and the flippers were stuck and not moving when the plunger lever was pressed.Review of the event history log showed an occurrence of "check syringe plunger sensor." the investigation found that the pump exhibited "check syringe plunger sensor" on power up and the plunger assembly was found dragging when the plunger moved in and out of the pump.The investigation determined that incorrect assembly by the user of the drive train and plunger cable was the cause of the reported issue.

• 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 (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12930916
• Report Number: 3012307300-2021-12249
• Device Sequence Number: 4802855
• Product Code: FRN
• UDI-Device Identifier: 10610586041259
• UDI-Public: 10610586041259
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K111386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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
• Device Model Number: 3500
• Device Catalogue Number: 3500-414
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/11/2021
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/04/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2007
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown