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

Lot Number 30200981

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

Event Date 12/19/2023

Event Type  Injury  

Event Description

5-fluorouracil (5-fu) compounded by (b)(6) on (b)(6) 2023.4000 mg in 225 ml in an ambulatory "balloon pump" (avanos homepump c-series elastomeric pump, lot#30200981, exp: 1/2/2025).These pumps are made and setup to administer the 225 ml over 46 (forty-six) hours.Patient hooked up to pump on (b)(6) 2023 at14:40.Expected the pump to run out around (b)(6) 2023 at 12:40.Patient reported that pump ran empty (b)(6) 2023 at "05:00, 7 hours early.Pharmacy verified via ivx software (photographs of preparation) that correct volume was added to pump prior to dispensing.Patient denied any leaking from pump.Nursing staff denied any issues with pump.Pump was inspected for defects - none found.Patient was educated on possible side effects to faster-than-planned infusion - veteran denied any side effects.Patient instructed to call provider if said side effects develop.Pharmacy has sequestered the 2 remaining avanos homepump c-series elastomeric pumps with lot#30200981, exp: 1/2/2025 pending outcome of this report.

• Brand Name: ELASTOMERIC HOME PUMP C-SERIES
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 18419180
• MDR Text Key: 331726632
• Report Number: MW5149669
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 30200981
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL 50MG/ML INJ.
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male