MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD SOLIS 2120; PUMP, INFUSION

Model Number 2120

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Investigation results completed on a smiths medical cadd solis vip pumps - 2120 pump.Device arrived in good physically condition.Event log substantiated complaint, as alarm displayed downstream occlusion.Testing visually detected bubble in the sensor seal.Action was taken to replace the dso sensor and unknown cause of event.

Event Description

Information received a smith medical cadd solis 2120 reported dso (downstream occlusion) no patient adverse reported.

Manufacturer Narrative

B5, h6: additional information.

Event Description

Information was received stating incident occured during testing; no patient involvement.

• Brand Name: CADD SOLIS 2120
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis, mn
• MDR Report Key: 9772600
• MDR Text Key: 181538386
• Report Number: 3012307300-2020-01618
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517126600
• UDI-Public: 15019517126600
• Combination Product (y/n): N
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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 Operator: Other
• Device Model Number: 2120
• Device Catalogue Number: 1-2127-0104-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Manufacturer Received: 02/29/2020
• Initial Date FDA Received: 02/29/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1