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

Model Number 13568

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2023

Event Type  malfunction  

Event 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
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16321768
• MDR Text Key: 309046807
• Report Number: 16321768
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 10680651135688
• UDI-Public: 10680651135688
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Date Report Sent to FDA: 01/31/2023
• Event Location: Home
• Date Report to Manufacturer: 02/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1