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

Model Number 2120

Device Problem Device Alarm System (1012)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One cadd solis vip pump was received in good physical condition.The event history log was reviewed and there was no error code present.Functional tests were performed and the reported error 44510 could not be duplicated.There was no fault found with the returned pump.

Event Description

Information was received indicating that a smiths medical cadd solis vip pump had an error 44510.There was no reported adverse event.

Manufacturer Narrative

Additional information.

Event Description

Incident occurred during preventive maintenance; no patient involvement.

• Brand Name: CADD SOLIS VIP PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9772566
• MDR Text Key: 181535861
• Report Number: 3012307300-2020-01751
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586042829
• UDI-Public: 10610586042829
• Combination Product (y/n): N
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0102-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1