MAUDE Adverse Event Report: HALYARD HEALTH, INC. HOMEPUMP C-SERIES; PUMP, INFUSION, ELASTOMERIC

Catalog Number C270050

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Fatigue (1849); Neuropathy (1983)

Event Date 09/27/2014

Event Type  malfunction  

Event Description

Patient reported to the dr the following: last week my chemotherapy pump delivered all of the medication in 2 days rather than 3.I was connected on thursday at 7 p.M.The infusion should have lasted until saturday evening.However, when i checked the device on friday evening it was nearly empty.At my usual 4 a.M.Wake-up time saturday morning, i checked the device and it was completely flat, indicating that the entire dose had completed.This was more than 12 hours ahead of schedule.All day friday and saturday i experienced great fatigue and was unable to do much except keep my eyes open.I also experienced significant neuropathy in both hands making it impossible to open bottles.The neuropathy has subsided but has not completely resolved.I hope you will be able to look into the infusion problem before thursday next week.Last week's experience is not one that i would not want to repeat.The visiting nurse who disconnected my pump on saturday said that her other patients using the same device also completed well ahead of schedule.

• Brand Name: HOMEPUMP C-SERIES
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH, INC.; 43 discovery suite 100; irvine, CA 92618
• MDR Report Key: 5207064
• MDR Text Key: 30637328
• Report Number: 5207064
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2015,10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: C270050
• Device Lot Number: 0201325987
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other