MAUDE Adverse Event Report: ST PAUL CADD; PUMP, INFUSION

Model Number 7400

Device Problem No Apparent Adverse Event (3189)

Patient Problem Swelling/ Edema (4577)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.

Event Description

It was reported the patient is experiencing swelling near her sq site but no redness, nodules, or irritation.The medic is aware.Patient is scheduled for a right heart catherization at the end of may and will discuss with medical office as it is believed the pah symptoms are not improving.Caregiver also stated one of her pumps (serial number (b)(4)) is not working and requires a code.The malfunction did not occur while in use.Patient is using her other pump currently.Patient said she changes batteries every 3 days and keeps batteries in pump when not in use but the pump lost programming.Pharmacy is sending a replacement pump.No patient injury was reported.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14691684
• MDR Text Key: 296332448
• Report Number: 3012307300-2022-11913
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586029554
• UDI-Public: 10610586029554
• 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: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7400
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female