MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PUMP CADD MS3; PUMP, INFUSION

Model Number 7400

Device Problems Inaccurate Delivery (2339); Patient Device Interaction Problem (4001)

Patient Problem Dyspnea (1816)

Event Date 10/28/2022

Event Type  Injury  

Event Description

Per (b)(6), cnss supervisor: (patient) admitted last few days due to increased shortness of breath.Hospital ended up finding out the pump was only giving half the dose.And the reason they believe this is because it is only delivering half the expected volume.In order to discharge her, we need two working pumps.Outbound call to patient and spouse who provided serial number (b)(4).Maintenance due date unspecified.She also stated she is doing better, but another cause of her worsening shortness of breath might have been because she is not as complaint as she should be with her adempas doses.Sq remunity specialty pharmacy fill patient.No additional information, details or dates are available at this time.Return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.Did the reported product fault occur while in use with the patient? yes, did the product issue cause or contribute to patient or clinical injury? yes, if yes, was any medical intervention provided? yes, is the actual product available for investigation? no, did we replace the product? the pump has been replaced; did the patient have a backup product they were able to switch to? yes.Was the patient able to successfully continue their therapy? yes i no, what was the patient instructed to do in order to continue their therapy? is the therapy life sustaining? yes.What is the outcome of the event? resolved ¿ resolved? ongoing? ongoing.Reported to (b)(6) by: health professional.

• Brand Name: PUMP CADD MS3
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15732351
• MDR Text Key: 303172584
• Report Number: MW5113061
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7400
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female