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

Model Number	7321
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Event or Problem Description
Hold ms 11/8 it was reported that during use, the device system under-infused.The patient presented to the clinic and it was noticed that the device system had infused only 20ml out of 106ml total volume at a rate of 2.4ml/hour.Per the reporter, the device system acted as if it was infusing, no alarm occurred, and the low volume and complete alerts occurred at the appropriate times.The device indicated that the full volume was infused and was empty.The device system was pulled from service and the patient was to return to receive the rest of the dose per physician order.Per the reporter, there were no patient adverse effects.The device was not to be returned to the manufacturer.
Additional Manufacturer Narrative
One sample was received for evaluation.The sample was received in unused conditions, decontaminated and inside in a plastic bag.Visual inspection revealed no damage.Functional testing was performed but the reported issue could not be replicated.No root cause could be determined as no device problem was found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No actions were taken.Email address: (b)(4).

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18091968
• Report Number: 3012307300-2023-10328
• Device Sequence Number: 6725982
• Product Code: FPA
• UDI-Device Identifier: 10610586029639
• UDI-Public: 10610586029639
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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 Model Number: 7321
• Device Catalogue Number: 21-7321-24
• Device Lot Number: 4354749
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown