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	10/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called to inform us infusystem 5 fu pump was not working.She called 1-800 number and they instructed her to come to clinic for new pump.

• 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: 8068511
• Report Number: 8068511
• Device Sequence Number: 11152359
• 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: 10/26/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 11/14/2018
• Type of Report(Section G): Thirty-Day
• 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