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

Model Number 21-7302-24

Device Problems Device Alarm System (1012); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2020

Event Type  malfunction  

Event Description

Information was received indicating that during use of a smiths medical cadd cassette reservoir, high pressure message was displayed on the cadd infusion pump.It was also reported that the alarm endured until cassette was changed.No patient consequences were reported.No adverse effects were reported.

Manufacturer Narrative

Other, other text: 11 units of cadd cassette reservoirs were returned to investigate the reported event of causing pumps to 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 sample were tested and the alarm was not activated.No further actions were taken.

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• 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: 10534728
• MDR Text Key: 206956084
• Report Number: 3012307300-2020-09295
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• 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: 08/20/2020
• 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