MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SETS; 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 while in use of a smiths medical cadd extension set, an audible alarm was noted, and infusion stopped.Subsequently, the cassette was changed.No patient consequences were reported.No adverse effects were reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.One unit was returned for evaluation.The unit was returned decontaminated inside a plastic bag without its original package.The sample was visually inspected at a distance of 12 to 24 inches and normal conditions of illumination.No discrepancies or damage was observed in the returned sample.The sample was set for accuracy testing using a pump to look for unusual function.The sample decontaminated received pass the accuracy test , thus the failure mode reported was not confirmed.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No corrective actions were taken.

• Brand Name: CADD EXTENSION SETS
• 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: jim vegel ; 6000 nathan lane north; ofc 518; minneapolis, MN 55442
• MDR Report Key: 12770791
• Report Number: 3012307300-2021-10839
• Device Sequence Number: 7233859
• 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): 04/30/2023

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: 04/26/2023
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 04/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Ethnicity: Hispanic