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

Device Problems Device Alarm System (1012); Obstruction of Flow (2423); Pressure Problem (3012)

Patient Problem Respiratory Distress (2045)

Event Date 11/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: 2 cadd pumps.

Event Description

Information was received indicating that the patient called to report a high pressure alarm on a cadd pump being used with a smiths medical cadd extension set.The patient troubleshooted, but could not find any obstructions in the line.The patient used a backup pump which ended up failing for the same issue.The patient went to the hospital where it was discovered that the pressure issue was due to the cadd extension tubing and not the patient's hickman line.The patient was not changing the extension set 3 times a week.The patient did experience difficulty breathing.The patient had a backup device and was able to continue the life sustaining infusion of veletri 1.5mg vial.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11120356
• MDR Text Key: 225253424
• Report Number: 3012307300-2021-00086
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR