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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2021

Event Type  malfunction  

Event Description

Information was received regarding a cadd cassette reservoir.It was reported that there were faulty cassettes.They stated that when they push the syringe containing the drug/diluent into the cassette, the medication leaks from the connector and within the cassette.They explained that it looked like the cassette popped from the inside.They can see solution outside of the cassette's inner bag.This is the 5th time it has happened since switching product.Patient had 2 mixes already made and they were going to try to make one more mix as backup, but they were concerned because they are having to waste drug due to the faulty cassettes.Patient's spouse was asked if they had extra cassettes that were of a different lot number, and they stated that they were all the same lot.They had a backup device for the life-sustaining infusion.There was no patient, or clinician injury associated with this occurrence.

Manufacturer Narrative

Other, other text: additional information was received indicating event date and patient details.

• Brand Name: CADD
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12903283
• MDR Text Key: 281503622
• Report Number: 3012307300-2021-12046
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male