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

Catalog Number C270050

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

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

Event Date 04/21/2023

Event Type  malfunction  

Event Description

Patient returned to clinic today to disconnect ambulatory chemotherapy pump that contained fluorouracil.When securing the pump to the patient on wednesday double verification was performed on clamp connections and that sensor was taped to patient abdomen.On (b)(6) 2023 as nurse was disconnecting the pump and removing the tape that secured the sensor, it was noted that there was a white powder under the tape around the sensor.A white powdery residue typically signifies a drug leak.The patient stated she did not notice any damp sensation or leaking from the tubing or pump.Md, pharm d, and operational pharmacy was notified.Per operations request, once pump was disconnected it was double bagged and returned to them so follow up could be made with the manufacturer.Patient denied any irritation, itching or discomfort at the site.Area was cleansed thoroughly with soap and water.Patient instructed to notify us of any skin changes to that area and provided with our card and after hours pager number.The area of where the white powder was deposited by the sensor (flow regulator) was a closed, continuous section of the infusion catheter.No local nursing procedure could cause a leak in this area.A leak could occur if the sensor (flow regulator) somehow was defective.The sensor is currently being sent back to the manufacturer for evaluation and testing.The results of this evaluation and testing are not yet available.If the sensor is found to be defective, further units from this lot of infusion pumps will need to be tested.If more defective units are found, the lot may need to be recalled.

• Brand Name: AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 17019997
• MDR Text Key: 316222440
• Report Number: MW5117956
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/24/2023

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 Catalogue Number: C270050
• Device Lot Number: 30225018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic