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

Model Number 21-7308-24

Device Problems Device Alarm System (1012); Partial Blockage (1065); Complete Blockage (1094); Obstruction of Flow (2423)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

It was reported the disposable caused the pump to not prime or run without a downstream occlusion alarm occurring and alarm would not resolve.No patient injury.No additional information.

Manufacturer Narrative

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

Manufacturer Narrative

Other text: d10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: three samples were received.A visual inspection found the samples in before use condition with no damage.During the functional testing, the samples were fully priming and connected without difficulty.No alarms were activated when the pump was set to run.The customer reported complaint was unable to be confirmed as the failure could not be replicated.A batch review was conducted to the lot number reported and the results concluded in no deviations and non-conformances were open during the manufacture of this lot related to the issue reported.

• Brand Name: CADD CASSETTE RESERVOIRS - 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: 16709725
• MDR Text Key: 312987194
• Report Number: 3012307300-2023-03892
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: 10610586032370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• 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

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7308-24
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 4342751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1