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

Model Number 21-7309-24

Device Problem Inaccurate Delivery (2339)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the disposable was not delivering the correct volume of the medical fluid to the patient.No patient injury reported.

Manufacturer Narrative

Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: one sample was received in used condition.A visual inspection found no damage.During the functional testing, the pump tube height measure did not pass the test but it was possible the sample was manipulated as it was received in used condition.During the accuracy test, the sample was able to be connected with no problem and the complaint was not confirmed.The failure mode could not be duplicated by functional testing.No root cause was able to be determined.A dhr review was unable to be completed as the lot number was not provided.

• Brand Name: CADD
• 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: 16856179
• MDR Text Key: 314455603
• Report Number: 3012307300-2023-04932
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586032387
• UDI-Public: 10610586032387
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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
• Device Operator: Health Professional
• Device Model Number: 21-7309-24
• Device Catalogue Number: 21-7309-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 07/22/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1