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

Model Number	21-7383-24
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received regarding a cadd administration set.It was reported that pump had difficulty delivering the infusion during prefilling.Customer notes, "instead of the usual 12-13 ml, it was 40 ml." after 14 hours in use, more than half of the infusion remained in the bag.The problem persisted even after replacing the pump.
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.Two used samples and seven unused samples were received for investigation.Visual inspection was performed per procedure.During the functional testing, one of the unused samples failed the functional testing, confirming the complaint.The root cause confirmed in the physical samples received and in the unit that failed delivery accuracy is tube arch height out of the specification range.A corrective and preventative action was opened to address the reported issue., corrected data: d1.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: 10962736
• Report Number: 3012307300-2020-12192
• Device Sequence Number: 19645860
• 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,User Facility
• 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: 03/17/2025
• Device Model Number: 21-7383-24
• Device Catalogue Number: 21-7383-24
• Device Lot Number: 3955195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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