MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS HOMEPUMP C-SERIES; PUMP, INFUSION, ELASTOMERIC

Model Number C 270050

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

Pt stated her 5fu did not infuse entirely.She stated one side of the ball deflated haf way and that's all.Pt stated thermometer probe remained attached and both clamps were opened.When pt took down c series, port was able to be flushed with saline without resistance.Believed to be faulty c series so patient was informed to keep the c series for pick up and evaluation.Device sent to manufacturer for testing and result was that device failed.Fda safety report id# (b)(4).

• Brand Name: AVANOS HOMEPUMP C-SERIES
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 14854956
• MDR Text Key: 295045798
• Report Number: MW5110576
• 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: 06/24/2022

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: 05/30/2024
• Device Model Number: C 270050
• Device Lot Number: 31061099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male