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	08/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called clinic this morning stating that his 5fu civi pump was backed up with blood from port tubing into infusion bag.He noticed this last evening.The infu system pump (walk med 350) had just stopped working and did not alarm.The face of the pump did have digital readings but was not infusing.He came to clinic for evaluation.New pump was assigned.Remaining drug dosage was recalculated and new bag connected.Port had to be reaccessed since it was unable to flush.Unable to assess how long pump was not infusing as there was no alarm for patient to be aware.

• 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: 8089568
• Report Number: 8089568
• Device Sequence Number: 11102414
• 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: 11/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2018
• 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