MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS PUMPS; PUMP, INFUSION, PCA

Model Number	2110
Medical Device Problem Codes	Device Alarm System (1012); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.One device was received for investigation.The device was visually inspected and functionally tested.The reported problem could not be duplicated.The complaint is not confirmed.No further action will be taken.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
Event or Problem Description
It was reported that the pump froze with an error.The pump discharged suddenly from full battery and the charging signal came back afterwards.There was unknown patient involvement and unknown patient harm/ adverse event reported.

• Brand Name: CADD SOLIS PUMPS
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19539537
• Report Number: 3012307300-2024-05039
• Device Sequence Number: 6216448
• Product Code: MEA
• UDI-Device Identifier: 15019517101027
• UDI-Public: (01)15019517101027(11)190925
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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
• Operator of Device: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0401-07L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown