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

Model Number 21-7002-24

Device Problems Leak/Splash (1354); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the pump under delivered as fluid leaked from the cassette.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Additional information: one cadd cassette reservoir was returned for analysis.The sample was visually inspected, at a distance of 12" to 24" and normal conditions of illumination.A syringe was used to infuse water into the assembly bag.The leak was detected in the assembly bag, specifically located in top corner near pump tube connection.A review of the manufacturing was conducted in order to verify that there are no situations of practices that might cause the issue.The bag loading operation in the cassette line was reviewed; no discrepancies were found.The segregation practice where the burst test takes place in the magnus production line was reviewed; no discrepancies were found.The most probable cause of the issue is that during the assembly process the bag loading operation of the bag was not handled property.As a correction; all sharp edges on foreign material removal tool were removed, to prevent bag damage that can lead to leaking issue.

• 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: 9531314
• MDR Text Key: 177395236
• Report Number: 3012307300-2019-07343
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586022128
• UDI-Public: 10610586022128
• Combination Product (y/n): N
• PMA/PMN Number: K843772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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: No Information
• Device Model Number: 21-7002-24
• Device Catalogue Number: 21-7002-24
• Device Lot Number: 3857626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1