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

Model Number	21-7383-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set was being used with pumps which were constantly giving error messages such as "air in the system".The pumps and batteries were replaced several times as it was initially assumed that the problem was with the pumps.The error messages persisted even with new pumps and batteries.The nurses were well trained and had been with the patients for a long time, so that excluded application errors.The administration set was changed and the pumps ran without errors.
Additional Manufacturer Narrative
Other text: additional information h6, h10.This remediation mdr was generated under protocol(b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.Three-hundred forty-five samples were received in their boxes within their original packaging.Visual inspection was performed at 12 to 16 inches under normal conditions of illumination.No abnormalities were detected during visual inspection.During the functional testing, fifty samples were primed without difficulty and no alarms were activated; the water could pass through the entire device.The failure mode was not confirmed.Root cause cannot be determined since the complaint was not confirmed due to the fact the returned samples were tested and successfully passed., corrected data: d1.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11957959
• Report Number: 3012307300-2021-05715
• Device Sequence Number: 1403420
• Product Code: FPA
• UDI-Device Identifier: 10610586027475
• UDI-Public: 10610586027475
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 05/19/2025
• Device Model Number: 21-7383-24
• Device Catalogue Number: 21-7383-24
• Device Lot Number: 3971522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown