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

Device Problem Infusion or Flow Problem (2964)

Patient Problems Purulent Discharge (1812); Erythema (1840); Itching Sensation (1943); Tissue Breakdown (2681); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Iv treprostinil patient with cadd legacy pumps.Per email from cnss, patient states that she had to go to er on (b)(6) 2023 to have picc line assessed for patency.Patient was having issues with occlusion alert on pump and was advised by prescriber to go to hospital.States no further issues with pump.Upon visit today, noted that picc line site was red with brown drainage to site.Patient reports having itchiness to site, believes its from the adhesive.Site noted to have redness, irritation, and skin breakdown from dressing.Patient had a tear in her dressing, states she had been scratching site and may have tom through dressing with acrylic nails.No further information known.Reported to cvs/caremark by health professional.

• Brand Name: CADD LEGACY PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16204962
• MDR Text Key: 307805922
• Report Number: MW5114383
• Device Sequence Number: 1
• Product Code: KGX
• 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: 01/13/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2023
• Patient Sequence Number: 1
• Treatment: OPSUMIT 10 MG; PICC; TREPROSTINIL
• Patient Sex: Female