MAUDE Adverse Event Report: HALYARD HEALTH/AVANOS MEDICAL, INC. HOMEPUMP C SERIES ELASTOMERIC PUMP BY HALYARD; PUMP, INFUSION, ELASTOMERIC

Lot Number 30028023

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2020

Event Type  malfunction  

Event Description

Halyard homepump c series malfunctioned.

• Brand Name: HOMEPUMP C SERIES ELASTOMERIC PUMP BY HALYARD
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH/AVANOS MEDICAL, INC.; 5405 windward parkway; alpharette GA 30004
• MDR Report Key: 10200486
• MDR Text Key: 196943978
• Report Number: MW5095240
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 06/24/2020

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: 30028023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR