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

Model Number	C270050
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 17269299
• Report Number: MW5119139
• Device Sequence Number: 14336185
• Product Code: MEB
• UDI-Device Identifier: 00193494135683
• UDI-Public: (01)00193494135683
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2025
• 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5 FLUOROURACIL. THERAPY END DATE:; 5 FLUOROURACIL. THERAPY START DATE:
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White