MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD HOMEPUMP C-SERIES AMBULATORY INFUSION SYSTEMS; PUMP, INFUSION, ELASTOMERIC

Model Number	13568
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Outpatient infusion therapy staff connected the home elastomeric pump.Two days later when the patient returned to have the pump disconnected, it was noted that the medication was still in the pump.All clamps were open on tubing.The patient¿s vascular access had good blood return and flushed appropriately.

• Brand Name: HALYARD HOMEPUMP C-SERIES AMBULATORY INFUSION SYSTEMS
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16321768
• Report Number: 16321768
• Device Sequence Number: 8645475
• Product Code: MEB
• UDI-Device Identifier: 10680651135688
• UDI-Public: 10680651135688
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2023
• Report Date (Section F): 01/31/2023

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 Model Number: 13568
• Device Catalogue Number: C270050
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 02/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/31/2023