MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AMBIT* PIB-PCA V1.5 SYSTEM W/SPIKE FILTER CASS; PUMP, INFUSION, PCA

Model Number	220574
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While attempting to start ambit pump, there was already a bolus given which had not been programmed into the pump yet.

• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 19070460
• Report Number: 19070460
• Device Sequence Number: 6994608
• Product Code: MEA
• UDI-Device Identifier: 00193494001308
• UDI-Public: (01)00193494001308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/15/2024
• Report Date (Section F): 03/15/2024

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: 220574
• Device Catalogue Number: 220574
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2024
• 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: 03/15/2024