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

Model Number	21-7450-24
Medical Device Problem Codes	Device Alarm System (1012); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per email (medwatch report #mw5106706, report date: (b)(6) 2022): inbound; husband reports cadd ms3 pump alarmed empty when it still had 1.0 ml left in cartridge, cartridge lot# 10210720.Replacement pumps sent.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: 13808167
• Report Number: 3012307300-2022-04686
• Device Sequence Number: 2083411
• 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
• 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
• Device Lot Number: 10210720
• Was Device Available for Evaluation?: No
• 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