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

Model Number 2110

Device Problem Pumping Stopped (1503)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths cadd®-solis ambulatory infusion pump displayed a red display alarm.There was no reported injury to the patient.

Manufacturer Narrative

One cadd®-solis ambulatory infusion pump was returned for analysis in good condition.The pump was found to be displaying error a08c, which reference to a adc_safety_signal.The reported issue was verified.The mpu board will be replaced in order to resolve the issue.

• Brand Name: CADD®-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8274837
• MDR Text Key: 134063828
• Report Number: 3012307300-2019-00273
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517099690
• UDI-Public: 15019517099690
• Combination Product (y/n): N
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0401-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1