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

Device Problem Application Program Problem (2880)

Patient Problems Dyspnea (1816); Chest Tightness/Pressure (2463)

Event Date 07/21/2018

Event Type  malfunction  

Event Description

Registered nurse in room giving patient discharge paperwork and patient switching from hospital cadd ms3 pump to personal home cadd ms3 pump.Patient accidentally spilt some remodulin from cartridge while placing it in her home pump.Informed patient that we would get another cartridge from pharmacy to replace.Patient started home pump in the mean time.Patient then complained to niece at bedside in (b)(6) (her native language) that she was having head pressure and chest pressure along with shortness of breath and complained that she felt really tired.Patient exhibited signs and symptoms of the side effects of a bolus of remodulin.Registered respiratory therapist and doctor called.Orders given to monitor patient for 2 hours, ekg and troponins to be completed.Upon frequent reassessment of patient, symptoms had subsided, vitals remained stable.Informed doctor, orders to discharge patient verbally given.Gave patient new tubing and new cartridge of remodulin, patient changed out tubing and cartridge to her home cadd ms3 pump and was discharged home.Biomed not able to investigate patient owned pump as it was taken home, when patient was discharged.Question presented to biomed: is it possible to change the language setting on pumps such as this? vendor rep.Returned biomed's call - to his knowledge he states the machines cannot be changed to different languages.Rep.States that the patients are informed at purchase, that if they have any problems, they can call the 1-800 number listed on the side of pump for assistance.The 1-800 nursing hot line has the availability of 250 languages, in their language bank.Identifying information not available.Patient owned pump.

• Brand Name: CADD MS3 PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; oakdale MN 55128
• MDR Report Key: 8068629
• MDR Text Key: 127117520
• Report Number: 8068629
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17520 DA