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

Model Number	204609
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called into the clinic after not being able to trouble shoot the issue of his home infusion pump even after calling the 800 number on the pump.Upon arrival, the pump was not infusing and had deleted the set program.A new pump was issued and patient continued with his infusion.Interruption of infusion lasted approx.1 1/2 hours.Md made aware- no harm towards patient noted.

• 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: 8109908
• Report Number: 8109908
• Device Sequence Number: 13886440
• 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): 11/06/2018
• Report Date (Section F): 11/06/2018

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 the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2018
• 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: 11/06/2018