MAUDE Adverse Event Report: ST PAUL CADD

Model Number 7300

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 01/26/2021

Event Type  malfunction  

Event Description

Patient reported that they noticed that there was a little hole on the cadd cassette tubing almost at the tip of the tubing close to the connection with the tubing while infusing.They stated since some medication was coming out of the tubing.Patient stated that they used the cassette for about 30 minutes.Patient changed to another cassette.Patient does not know from which lot the product came from.No adverse patient effects were reported.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A functional test was performed.Sample received: one (1) sample was received on 14/apr/2021.Sample consists in from p/n 21-7302-24 l/n unknown in used conditions, without its original packaging and with its certificate of safe handling.Functional testing: the sample unit was fill with water using a syringe following the ifu-10009799-002 rev100 ifu, cassette, 21-7302-24" to detect any leakage.Results: a leak was found between the female connector and tube.The complaint is confirmed.The most probable root cause is that the cassette with leak in the bonding joins was not properly segregate during leak test operation at the moment to re-tested the parts.The cause of the reported problem was traced to the manufacturing process.

• Brand Name: CADD
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11390977
• MDR Text Key: 233948279
• Report Number: 3012307300-2021-01627
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7300
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1