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

Model Number 21-7308-24

Device Problems Device Alarm System (1012); Obstruction of Flow (2423)

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

Event Date 04/01/2023

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.

Event Description

It was reported, that the occlusion alarm does not sound.And that during the use of the product, the customer noticed no "high pressure" alarm went off at all.If the child is left with the tube connected, the child will back bleed.So the occlusion alarm should be sounded before the patient is taken.Normally, the occlusion alarm sounds in tens of seconds to a few minutes.On the first day, it took 23 minutes, 15 minutes for inspection on the second day, and 2-3 minutes for inspection on the third day.No patient injury was reported.

Manufacturer Narrative

Other text: d10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: one sample was received in used condition.The visual inspection found that it was received without the blue clip and white cap.No other damage was found.During the functional testing, the sample was filled with water and set to run with a pump.The sample was fully priming and connected without difficulty.The customer complaint was unable to be replicated.A root cause was unable to be confirmed.There is no non-conformance or deviation related to the failure reported in the device history record for the component associated.By the date of this complaint investigation report no more complaints related to the failure mode and lot number were reported in the last 12 months.

• 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: 16911897
• MDR Text Key: 315008511
• Report Number: 3012307300-2023-05561
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: 10610586032370
• 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: Foreign,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: 21-7308-24
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 4349095
• 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: 05/02/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 07/22/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1