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

Model Number	4000
Medical Device Problem Codes	Device Alarm System (1012); Battery Problem (2885)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation results: one medfusion pump was returned for investigation in used condition.The tamper seals were intact and the pump was in excellent condition.There were no battery related issues in the event history log (ehl).The ehl did show a message for a recommended maintenance due to an unspecified alarm.When the pump was powered up, the maintenance message reappeared.There were no messages relating to the battery.One of the customer related complaints (required maintenance) was therefore replicated.At the time of the investigation the battery level was at 46%, and the battery was charging as expected.No fault was found with the pump.The device only required annual maintenance.The pump underwent routine maintenance.The batteries were also replaced as a preventive measure.The pump subsequently passed all the functional tests.
Event or Problem Description
It was reported that the medfusion 4000 pump was alarming.The pump needed new batteries.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: h2: see a1, b5 and h6 (patient code).
Event or Problem Description
Additional information was received indicating that the pump is used for sales demonstration and there was no patient involvement.

• Brand Name: MEDFUSION
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10424841
• Report Number: 3012307300-2020-08286
• Device Sequence Number: 2999982
• Product Code: FRN
• UDI-Device Identifier: 10610586043581
• UDI-Public: 10610586043581
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/28/2020

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: 4000-0105-249
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1