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

Model Number	E101000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pharmacy technician used a baxter repeater pump to fill a 100 ml/hour 100ml eclipse homepump.After finishing the dose, the tech noticed liquid on the hood surface.Upon examination of the eclipse, the tubing was leaking where it connects to the inline filter.Three of the six doses made were leaking from the same spot.We quarantined the lot # (30170380) and made all new doses using a different lot #.On (b)(6) 2022, a patient called in reporting the same problem.He had discarded the leaking dose.Fda safety report id (b)(4).

• Brand Name: HOMEPUMP ECLIPSE ELASTOMERIC PUMP
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA
• MDR Report Key: 15198334
• Report Number: MW5111401
• Device Sequence Number: 6293234
• Product Code: MEB
• UDI-Device Identifier: 00193494135492
• UDI-Public: 00193494135492
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/08/2022
• 2 Devices were Involved in the Event: 1 2

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: 06/21/2024
• Device Model Number: E101000
• Device Catalogue Number: E101000
• Device Lot Number: 30170380
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown