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

Model Number	21-7333-24
Medical Device Problem Codes	False Alarm (1013); Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device caused the attached pump to give false "air in line" alarms.
Additional Manufacturer Narrative
One cadd administration set was returned for the evaluation of the reported issue.A dhr, device history review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.A visual inspection was performed and no discrepancies were detected on the sample.A functional test was also performed and no difficulty was detected during the priming and no alarms was activated.Also, no air bubbles were found in any of the samples tested; thus the failure mode reported was not confirmed.Root cause could not be determined since the complaint was not confirmed due to the fact the sample was tested and successfully passed.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11497610
• Report Number: 3012307300-2021-02134
• Device Sequence Number: 14831017
• Product Code: FPA
• UDI-Device Identifier: 10610586043239
• UDI-Public: 10610586043239
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 21-7333-24
• Device Catalogue Number: 21-7333-24
• Device Lot Number: 3949610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 05/16/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1