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

Model Number	21-7450-24
Medical Device Problem Codes	Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per medwatch mw5106541: inbound; pt reports she has noticed approx 04 ml treprostinil left in her cadd ms3 syringes when pump alerts time to change and/ or empty.No lot numbers available and pt will start having her wrappers and notify of further issues.No further details provided.

• Brand Name: CADD
• Common Device Name: 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: 13808548
• Report Number: 3012307300-2022-04688
• Device Sequence Number: 19924926
• Product Code: FRN
• UDI-Device Identifier: 10610586028694
• UDI-Public: 10610586028694
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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 Model Number: 21-7450-24
• Device Catalogue Number: 21-7450-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown