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

Model Number 21-7302-24

Device Problems Increase in Pressure (1491); Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that during use of a smiths medical cadd medication cassette reservoir, frequent high-pressure messages occurred.It was reported that an alarm went off shortly, several times, with indication of high-pressure on the screen.The patient aspirated the leftover medication from the cassette, noting 10mls less of medication over a period of 24 hours.There were no reported adverse effects.

Event Description

Investigation completed and summarized in h 10.

Manufacturer Narrative

Investigation completed on a smiths medical cadd cassette reservoirs were returned to investigate the reported event of high pressure alarm.The units were visually inspected at a distance of 12" to 16" under normal conditions of illumination.No obstructions nor occlusion were detected in any of the cassette received.A functional test was also performed to look for unusual functions, but the reported issue could not be replicated.Root cause could not be determined since the complaint was not confirmed due to the fact the samples were tested and the alarm was not activated.No further actions were taken.Device engineering protocol were reviewed and this revealed 100 % performance check prior to release of product.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10554203
• MDR Text Key: 207550271
• Report Number: 3012307300-2020-09505
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1