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

Model Number	204609
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Call received from the home iv nurse stating that she was at the patient's home to disconnect the patient from his pump.Pump read empty, patient was disconnected and then the nurse realized none or little of the intended med had been infused.Patient came to the clinic with his pump and the uninfused bag of chemo in the (b)(6) bag.Med discarded and covering physician made aware.Patient aware, no readministration of medication at this time.

• Brand Name: WALKMED®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): WALKMED INFUSION LLC; 14190 east jewell ave unit 10; aurora CO 80012
• MDR Report Key: 8503358
• Report Number: 8503358
• Device Sequence Number: 18881665
• 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): 03/26/2019
• Report Date (Section F): 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 204609
• Device Catalogue Number: WALKMED 350VL
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 70
• Date Report Sent to FDA: 03/26/2019