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	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came to clinic to evaluate pump malfunction.Walkmed 350vl (b)(4).Pump alarmed at 0300.Patient tried changing battery and called infu system support when pump continued to alarm.He was instructed to clamp pump and come to clinic in am.Port with positive blood return.Pump infused 11 hrs before alarming.When pump checked message displayed er u (system malfunction).New pump was issued to patient and infusion rate adjusted to finish in 46 hrs.

• 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: 8407251
• Report Number: 8407251
• Device Sequence Number: 420320
• 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): 02/27/2019
• Report Date (Section F): 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 204609
• Device Catalogue Number: WALKMED 350VL
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 58
• Date Report Sent to FDA: 02/27/2019