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

Model Number 21-7302-24

Device Problems Increase in Pressure (1491); Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

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.

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: 10556827
• MDR Text Key: 207623358
• Report Number: 3012307300-2020-09543
• 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: 01/05/2021

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: 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
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 12/06/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1