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

Model Number	4000
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a smiths medical medfusion pump had a primary audible alarm error code.There was no patient involvement.
Additional Manufacturer Narrative
Other, other text: device evaluation - the device was returned for evaluation.The device was given functional testing; this showed the device met with specifications.The "primary audible alarm" was seen in the device event history log; however this issue was not duplicated during testing.Internal inspection showed no damage to connectors or other components that could induce this condition.The reported issue was not confirmed device-caused during investigation.

• Brand Name: MEDFUSION
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11563936
• Report Number: 3012307300-2021-02468
• Device Sequence Number: 2955222
• Product Code: FRN
• UDI-Device Identifier: 15019517070750
• UDI-Public: 15019517070750
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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
• Operator of Device: No Information
• Device Model Number: 4000
• Device Catalogue Number: 4000-0106-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1