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

Model Number	21-2188-25
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).This is a supplied item; the device history record (dhr) is at the supplier.No product sample was received; therefore, visual and functional testing could not be performed and root cause could not be determined.
Event or Problem Description
It was reported that the lock has fallen out or/snapped off of the pump.No patient injury was reported.

• Brand Name: CADD-SOLIS INFUSION SYSTEM
• 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: 15649243
• Report Number: 3012307300-2022-25604
• Device Sequence Number: 12271122
• Product Code: FRN
• UDI-Device Identifier: 10610586035029
• UDI-Public: 10610586035029
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 21-2188-25
• Device Catalogue Number: 21-2188-25
• Device Lot Number: W971340/11
• 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: 10/05/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown