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

Model Number	3500-0600-00
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
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported the pump exhibited a primary audible alarm.No patient injury reported.
Additional Manufacturer Narrative
One infusion pump was received for evaluation.Visual inspection found the tamper seals to be intact.The device was observed to be in good condition.The device?s event history log was reviewed for evidence of the reported problem, ?primary audible alarm power on self-test? found in the log several times and ?acu watchdog? as a sympathy alarm.To conduct functional testing the device was powered on and had an occlusion test performed.Upon testing, the reported problem was unable to be duplicated.Unable to determine the intermittent of the error.Audio test was performed which passed.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.Service history review identified this device was last serviced in may 2022 and there was no indication of a service issue during the investigation.

• Brand Name: MEDFUSION 3500 PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16728359
• Report Number: 3012307300-2023-04055
• Device Sequence Number: 6663813
• Product Code: FRN
• UDI-Device Identifier: 10610586041259
• UDI-Public: 10610586041259
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/17/2023

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: Other
• Device Model Number: 3500-0600-00
• Device Catalogue Number: 3500-0600-00
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/30/2023
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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