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

Catalog Number 21-7022-24

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported the medication did not infuse.The disposable and the pump were connected to a patient when the event occurred.The device's settings read: continuous infusion rate: 3.3; reservoir volume: 5150; given: none infused; air detector: off; upstream sensor: off; length of infusion: 46 hours; lock level: 2.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.

• Brand Name: CADD ADMINISTRATION SETS - NON-FLOW STOP
• Type of Device: 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: 18145711
• MDR Text Key: 328388245
• Report Number: 3012307300-2023-10543
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586019791
• UDI-Public: 10610586019791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7022-24
• Device Lot Number: 4381354
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1