MAUDE Adverse Event Report: ST PAUL CADD MS3 INFUSION CARTRIDGE; INFUSION PUMP

Model Number	21-7450-24
Medical Device Problem Codes	Leak/Splash (1354); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating a smiths medical, cadd-ms 3 cartridge, was leaking between the cartridge and tubing of the pump.No adverse patient effects were reported.No additional information is available at this time.
Additional Manufacturer Narrative
Additional contact information: (b)(6).

• Brand Name: CADD MS3 INFUSION CARTRIDGE
• Common Device Name: INFUSION PUMP
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12932459
• Report Number: 3012307300-2021-12284
• Device Sequence Number: 4869526
• Product Code: FRN
• UDI-Device Identifier: 10610586028694
• UDI-Public: 10610586028694
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

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: 09/17/2021
• Initial Report FDA Received Date: 12/06/2021
• 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: Female
• Patient Weight: 83 KG