MAUDE Adverse Event Report: ST PAUL MEDFUSION 3500 PUMP; INFUSION PUMP

Model Number	3500
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the pump failed the occlusion test due to "system failure: primary audible alarm background test." it is unknown if there was any patient involvement or any adverse effects.
Additional Manufacturer Narrative
Additional information was received indicating there was no patient involvement (updated h6 event problem patient code).
Additional Manufacturer Narrative
The device was returned to smiths/icu medical.There were no signs of external damage.The error history log cited a primary audible alarm bgnd test." the reported problem could not be duplicated.The speaker was replaced as a preventative measure.No causes or potential causes to the customer's reported problem were found during the dhr review.

• Brand Name: MEDFUSION 3500 PUMP
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14190200
• Report Number: 3012307300-2022-06896
• Device Sequence Number: 19907896
• Product Code: FRN
• UDI-Device Identifier: 10610586041259
• UDI-Public: 10610586041259
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Followup
• Report Date (Section B): 07/14/2022

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: 3500-0600-00
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/01/2022
• 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: 03/29/2022
• Supplement Date Received by Manufacturer: 05/06/2022; 06/24/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 06/01/2022; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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