MAUDE Adverse Event Report: WALKMED LLC WALKMED®; PUMP, INFUSION

Model Number	204609
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called clinic to inform nurse that infu system pump was alarming at home.Patient came to clinic, pump screen flashing 'err.U', according to manufacturer trouble shooting guide this is a system malfunction and pump needs to be replaced.

• Brand Name: WALKMED®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): WALKMED LLC; 14190 east jewell ave unit 10; aurora CO 80012
• MDR Report Key: 8068512
• Report Number: 8068512
• Device Sequence Number: 13842398
• Product Code: FRN
• UDI-Device Identifier: 00859695006077
• UDI-Public: (01)00859695006077
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/07/2018
• Report Date (Section F): 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 204609
• Device Catalogue Number: WALKMED 350VL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/07/2018