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

Model Number 21-7302-24

Device Problem Product Quality Problem (1506)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr, 803.56, when additional reportable information becomes available.No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.Device evaluation: one photo was provided by the customer which 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.Results: the photo shows a pouch label of part number and lot number.The reported failure mode, no disposable alarm is not observer in the picture.Therefore, the complaint cannot be confirmed.Functional testing: no product has been received to conduct a functional test.Mitigation: the following are the process controls for the failure mode reported; bag loading operation ay bag folds from each side toward the center approximately 6.6 mm (1/4 inch) to 9.5 mm (3/8 inch) to assure the correct position of the ay bag.The pump tube is adjusted between ffp arch and hooks.During assembly process following the visual aid av-0198 rev 100.Detection: the following detection mitigations are placed in the manufacturing process to detect pump alarms; per pm-1011 rev 124, leak testing, install ffp 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.Per pm-1012 rev 104, cassette in process testing production performs an accuracy test.Following the pm-322 rev 106 accuracy test procedure; takes a sample of 3 parts at shift start-up the beginning of every job, at least every 5 hours.Per qp-67-2265 rev 105, quality procedure for disposable; quality takes a sample of 15 units at an interval of 2 hours plus or minus 30 minutes, prior to placing product in bag.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 analyzing the photo provided, the root cause cannot be determined.Action taken: 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.A device history record (dhr) review was conducted.Which, indicated all inspections were completed and no issues were noted during manufacture.

Event Description

It was reported, the disposable caused the pump to alarm.No disposable attached.No disposable pump won't run.No patient injury reported.

• Brand Name: CADD CASSETTE RESERVOIRS WITH 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: 16762023
• MDR Text Key: 313523703
• Report Number: 3012307300-2023-04253
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040636
• 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
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1