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

Device Problems Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  malfunction  

Event Description

Information was received indicating that a patient using a cadd-ms 3 pump for treatment of pulmonary arterial hypertension, infusing remodulin (2.5mg/ml, dose 1.25 ng/kg/min via subcutaneous route) did not think the remodulin was infused.It was reported that the site was pulled out due to site pain and site redness; site was reported to be swollen and hot, itchy and hard.Per reporter no further details were provided.

Manufacturer Narrative

Additional contact information: (b)(6).

• Brand Name: CADD MS3 INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13261187
• MDR Text Key: 284509457
• Report Number: 3012307300-2022-00793
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 82 KG