MAUDE Adverse Event Report: KIMBERLY-CLARK / AVANOS MEDICAL (LAB) - IRVINE HOMEPUMP C-SERIES PORTABLE PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number C270020

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 05/02/2019

Event Type  No Answer Provided  

Event Description

Pt was to have a 96 hour infusion of fluorouracil which started on 4/22.Therefore, home pump c-series pump should have finished infusing on 4/26.Pt presented to infusion clinic on 4/25 stating the pump completed infusing early this morning.Pump was checked and was correct pump ((b)(4)).Fda safety report id# (b)(4).

• Brand Name: HOMEPUMP C-SERIES PORTABLE PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): KIMBERLY-CLARK / AVANOS MEDICAL (LAB) - IRVINE
• MDR Report Key: 8586752
• MDR Text Key: 144412731
• Report Number: MW5086409
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C270020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1