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

Model Number HOMEPUMP SERIES C

Device Problem Failure to Infuse (2340)

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

Event Date 06/07/2020

Event Type  No Answer Provided  

Event Description

Halyard homepump c series did not infuse lot # 30028023.

• Brand Name: HOMEPUMP C SERIES ELASTOMERIC BY HALYARD
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH / AVANOS MEDICAL, INC.; 5405 windward parkway ; alpharetta GA 30004
• MDR Report Key: 10142778
• MDR Text Key: 195002251
• Report Number: MW5094936
• 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: 06/09/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: HOMEPUMP SERIES C
• Device Lot Number: 300028023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR