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

Model Number	21-7310-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the product involved was not reported to smiths medical.
Event or Problem Description
It was reported that when the smiths medical cassette was attached to a smiths medical pump, the pump alarmed "no disposable." new cassette compounded : hydromorphone 5 g 250ml.
Additional Manufacturer Narrative
Other text: the device was received for evaluation.Visual and functional testing were performed and the reported issue was not confirmed.Visual inspection did not reveal any damage.During functional testing, the sample was filled and primed per testing protocol and the reported issue could not be duplicated.Manufacturing controls are in place to help prevent occurrence of the reported issue.A manufacturing device history review (dhr) was not performed because the lot number was not provided.The root cause for the reported issue could not be determined.Complaint trends will continue to be monitored.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms # (b)(4).

• Brand Name: CADD
• 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: 11944655
• Report Number: 3012307300-2021-05618
• Device Sequence Number: 19097853
• Product Code: FPA
• UDI-Device Identifier: 10610586032394
• UDI-Public: 10610586032394
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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
• Device Model Number: 21-7310-24
• Device Catalogue Number: 21-7310-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 06/06/2021
• Supplement Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male