MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET

Model Number 21-7381-24

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

Event 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
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 12414757
• MDR Text Key: 269578519
• Report Number: 3012307300-2021-09106
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027468
• UDI-Public: 10610586027468
• Combination Product (y/n): N
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1