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

Model Number	2110
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the air detector was not working.There was no patient involvement.
Additional Manufacturer Narrative
One device was returned for repair.There was no relevant event history and no relevant service history.The primary reportable complaint that the air detector was not working was confirmed by functional testing.Device failed air detector tests.Noted a missing battery door on unit during visual inspection.Noted main board failed functional testing.Replaced air detector, main board, and battery door.Device passed post repair functional tests and functioned as designed.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• 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: 20212183
• Report Number: 3012307300-2024-09096
• Device Sequence Number: 18093007
• Product Code: MEA
• UDI-Device Identifier: 10610586038822
• UDI-Public: (01)10610586038822(11)150617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: 21-2112-0300-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2015
• 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