MAUDE Adverse Event Report: CADD ADMINISTRATION SET

Model Number	21-7381-24
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was in use for infusion of parenteral nutrition.The user facility stated the iv bag was filled with 1632 ml (intended to be infused) and 100 ml overfill.The reporter stated the infusion ended and more fluid had been administered than was programmed.No adverse effects reported.

• Brand Name: CADD ADMINISTRATION SET
• MDR Report Key: 12414757
• Report Number: 3012307300-2021-09106
• Device Sequence Number: 14317134
• Product Code: FPA
• UDI-Device Identifier: 10610586027468
• UDI-Public: 10610586027468
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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
• Operator of Device: No Information
• Device Model Number: 21-7381-24
• Device Catalogue Number: 21-7381-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 09/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1