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

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Dyspnea (1816); Confusion/ Disorientation (2553)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Adverse event|required intervention to prevent permanent impairment/damage.

Event Description

Information was received indicating that a smiths medical, cadd medication cassette did not attach correctly, patient did not hear an alarm, resulting in patient being off remodlin for about 36 hours, infusion information reported was 10mg, dose, 210ng.Kg.Min, at a continuous rate intravenously.Treatment for pulmonary arterial hypertension.It was reported the patient was advised by support and the doctors office to go to the emergency room as the patient was exhibiting some shortness of breath and difficulty with focus.Per reporter the patient stated the pump was working and the cassette was the issue.It was also reported the product fault may have contributed to injury, although no further information was supplied.

• Brand Name: CADD MEDICATION CASSETTE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 13060679
• MDR Text Key: 282624743
• Report Number: 3012307300-2021-13156
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male