MAUDE Adverse Event Report: HALYARD SALES/AVANOS MEDICAL, INC. HOME PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number C270050

Device Problem Failure to Infuse (2340)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2020

Event Type  malfunction  

Event Description

Homepump failed to infuse all of 5fu medication.

• Brand Name: HOME PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD SALES/AVANOS MEDICAL, INC. ; alpharetta GA
• MDR Report Key: 10860554
• MDR Text Key: 217174989
• Report Number: MW5097953
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• 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: 11/16/2020

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 Expiration Date: 03/03/2023
• Device Model Number: C270050
• Device Lot Number: 20037281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 56