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

Model Number	21-7040-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during pre-test of a smiths medical cadd extension set, an audible alarm was noted, and infusion stopped.Subsequently, the cassette was changed.No patient was involved in this event.No adverse effects were reported.
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.One sample was received without their original packaging, in used condition, decontaminated and inside in a plastic bag.Visual inspection was performed at 12 to 16 inches under normal conditions of illumination.Visual inspection showed no discrepancies or damage was observed in the returned sample.During the functional testing, the reported issue was unable to be duplicated.The complaint was not confirmed.The root cause was unable to be determined.No action was taken., corrected data: d1.

• Brand Name: CADD EXTENSION SET
• 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; ofc 518; minneapolis, MN 55442
• MDR Report Key: 12770995
• Report Number: 3012307300-2021-10841
• Device Sequence Number: 11816567
• Product Code: FPA
• UDI-Device Identifier: 10610586020223
• UDI-Public: 10610586020223
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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: Lay User/Patient
• Device Expiration Date: 09/02/2024
• Device Model Number: 21-7040-24
• Device Catalogue Number: 21-7040-24
• Device Lot Number: 3873551
• 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: 10/10/2021
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female