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

Model Number 21-7002-24

Device Problems Failure to Deliver (2338); Inaccurate Delivery (2339)

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

Event Date 03/12/2023

Event Type  malfunction  

Event Description

It was reported that the pump alarmed cassette was empty when it was not.No patient injury reported.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Evaluation: one) video was attached to the complaint created; this video was provided by the customer.The video was used to conduct the device analysis since the physical unit, by the time this investigation is being documented, has not been received in the tijuana site.The disposable was observed to be empty with the line not attached to the air detector and the distal end luer connector attached to an extension line; no damage or dysfunctional conditions are observed.In the video an alarm beep is heard, and the pump displays the message (air detector off).The reported failure mode, causes pump to alarm, is confirmed.Functional testing: no product has been received to conduct a functional test.Results: if the device arrives, smiths medical will reopen this complaint to include in the investigation the physical sample returned.Mitigation below are the controls during manufacturing process for the failure mode.Loading operation these are the current mitigations implemented in the process to prevent delivery issues: leak testing, install clip and luer capping production performs a 100% in process inspection, to verify for occlusions, kinked tubing, components damaged, verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.Procedure production performs an accuracy test 15 units at an interval of two hours plus or minus 30 minutes, prior to placing product in bag, in order to verify for occlusions, kinked tubing and verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.After reviewing the mitigations that are performed during the manufacturing process to detect pump alarms, and review of the video provide, the root cause cannot be determined.No corrective actions are required because the mitigations on place were revised and are executing as is determined by procedure.This failure will continue to be monitored to determine if new actions need to be taken.

Manufacturer Narrative

Email address: (b)(6).Corrected data: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture., corrected data: see h10.

• Brand Name: CADD CASSETTE RESERVOIRS - 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: 16657364
• MDR Text Key: 312462279
• Report Number: 3012307300-2023-03347
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586022128
• UDI-Public: 10610586022128
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K843772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7002-24
• Device Catalogue Number: 21-7002-24
• Device Lot Number: 4294015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1