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

Model Number C270050

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2023

Event Type  malfunction  

Event Description

Patient connected to home infusional pump of 5-fu on tuesday per standard operating procedures.Pump contained a volume of 230ml, (104 ml 5-fu and 126 ml ns) when patient came in thursday for disconnect, the pump had only partially infused its contents.Pump was examined by oncology pharmacist, rn and rn navigator.All connections/lines were checked and picc line was patent.Oncologist was informed and ordered to dc the pump as is.The picc line flushed well once pump was disconnected.It is estimated the patient received about half of his infusional dose of 5-fu (115ml).

• Brand Name: AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 17269299
• MDR Text Key: 318607223
• Report Number: MW5119139
• 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: 06/30/2023

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 Model Number: C270050
• Device Catalogue Number: C270050
• Device Lot Number: 30225018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2023
• Patient Sequence Number: 1
• Treatment: 5 FLUOROURACIL. THERAPY END DATE:; 5 FLUOROURACIL. THERAPY START DATE:
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White