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

Model Number	2120
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths cadd®-solis vip ambulatory infusion pump displays an alarm that the cassette is not attached properly everytime the cassette is removed.There was no patient involvement.
Additional Manufacturer Narrative
One cadd solis vip pump was returned for analysis.Visual inspection performed, and product found with latch lever loose.Event history log review was performed and found no evidence of reported problem.Visual inspection and cassette attach and detach downstream occlusion sensor (dso) and upstream occlusion sensor (uso) testing were performed.The customer's reported problem was confirmed.According to the investigation, the pump dso was out of calibration which caused the reported problem.Service's recalibrated the pump downstream occlusion sensor to correct the reported problem.The problem source of the reported problem is unknown.

• Brand Name: CADD®-SOLIS VIP AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8506112
• Report Number: 3012307300-2019-01566
• Device Sequence Number: 17881069
• Product Code: FRN
• UDI-Device Identifier: 15019517126587
• UDI-Public: 15019517126587
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: Other
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0104-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1