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

Model Number 7400

Device Problems Therapeutic or Diagnostic Output Failure (3023); Program or Algorithm Execution Problem (4033)

Patient Problem Respiratory Insufficiency (4462)

Event Type  Injury  

Event Description

Patient reports that they were hospitalized from (b)(6) 2023 due to shortness of breath and fluid in their lungs.Patient states md is aware.Onset and resolution dates/status of symptoms unknown.Patient also reports that while hospitalized, pump serial number (b)(4) maintenance due 01/12/2024 lost programming.Patient did not state when they noticed that the pump had lost programming.Unknown if patient had the malfunctioning pump with them in the hospital.Patient has been infusing on their back up pump, no break in therapy.Pharmacy is replacing malfunctioning pump.No further info, details or dates available.Sq remodulin ms3 patient.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? yes; did we [mfr] replace the device? yes; did the pt have a backup device they were able to switch to? yes.Was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD MS3 PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16398046
• MDR Text Key: 309895701
• Report Number: MW5115004
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2024
• 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
• Treatment: OPSUMIT ; REMODULIN
• Patient Sex: Male