MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7383-24
Medical Device Problem Code	Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.No defects nor workmanship defects were detected during visual inspection.The pump was set running and the alarm was not activated, also no air line was detected.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample was tested and the alarm was not activated.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that an air alarm was detected three times with the same lot number.The incident was noted between three and four hours of use of the product.The user observed that the filter was half full of solution (white color observed halfway).The user used a different lot number.No patient injury was reported.

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15396879
• Report Number: 3012307300-2022-18416
• Device Sequence Number: 5007298
• Product Code: FPA
• UDI-Device Identifier: 10610586027475
• UDI-Public: 10610586027475
• Combination Product (Y/N): N
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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: Lay User/Patient
• Device Expiration Date: 09/17/2024
• Device Model Number: 21-7383-24
• Device Catalogue Number: 21-7383-24
• Device Lot Number: 3869362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown