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

Model Number C270050

Device Problems Deflation Problem (1149); Failure to Infuse (2340)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A 5fu infusion initiated on (b)(6) 2023.Patient returned to the infusion center on (b)(6) 2023 to have their home infusion pump disconnected.The patient noted that the pump did not "deflate".Upon examination it was observed that very little of the solution contained in the pump had infused.The provider was contacted and orders were given for another pump to be made and infused.The pump used was avanos c-series home pump, model c270050, lot number 30208252 (failed pump).

• Brand Name: AVANOS C-SERIES HOME PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 17127589
• MDR Text Key: 317224700
• Report Number: MW5118374
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: C270050
• Device Lot Number: 30208252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL (5-FU)
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White