MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Information (3190)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that the drug solution remained in a smiths medical cadd cassette reservoir.A liquid sending test was conducted in the hospital using a cadd legacy pca pump and errors appeared.There was no problem found with the pump.The cassette was checked and there was an error of -12%.There was no patient injury and no additional patient information was provided.

Manufacturer Narrative

Additional information: d10, h6, h10.Device evaluation: one smiths medical cadd cassette reservoir was returned for analysis in a used condition.Visual inspection found the cassette to be in a good condition.Accuracy testing was performed and passed successfully.During analysis, the reported event was not able to be duplicated.Based on the evidence, the complaint was not confirmed, and no fault was found.

• Brand Name: CADD CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9531773
• MDR Text Key: 177393717
• Report Number: 3012307300-2019-07363
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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: Other
• 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: 02/17/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 03/08/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CADD LEGACY PCA PUMP