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

Model Number	21-7323-24
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Priming Problem (4040)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cadd administration sets - flow stop experienced a malfunction.It was reported that when using the administration set there was difficulty experienced during priming the pump and there was also issues with under delivery.The issue occurred during testing.
Additional Manufacturer Narrative
40 cadd administration sets was returned for evaluation of failed accuracy testing.A device history review, dhr, was performed and no problems or issues were identified.A functional testing was performed to investigate the reported issue and the reported issue was able to be confirmed.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is was noted to be manufacturing.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10488397
• Report Number: 3012307300-2020-09024
• Device Sequence Number: 2476328
• Product Code: FPA
• UDI-Device Identifier: 10610586039614
• UDI-Public: 10610586039614
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: Health Professional
• Device Expiration Date: 11/26/2024
• Device Model Number: 21-7323-24
• Device Lot Number: 3910176
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 10/04/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1