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

Model Number	3500-0600-00
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned device was received in good physical condition but the bottom and right plunger cases were cracked.Evidence of reported problem in event log was found.During the evaluation of the device, all buttons worked well with no issues.There was a maintenance is recommended alarm at start-up and you have to hit the silence button on the keypad to move past it.This was determined to be a customer issue.The cracked cases will be replaced as well as the battery and a slightly contaminated interconnect board.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
Event or Problem Description
Information was received indicating that a smiths medical pump's buttons were not responding.There was no reported adverse events.

• Brand Name: MEDFUSION
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10417970
• Report Number: 3012307300-2020-08237
• Device Sequence Number: 2757787
• Product Code: FRN
• UDI-Device Identifier: 10610586041259
• UDI-Public: 10610586041259
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/17/2020

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?: No
• Operator of Device: No Information
• Device Model Number: 3500-0600-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1