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

Model Number 2120

Device Problem Device Alarm System (1012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: one cadd solis vip was returned for investigation in good condition.Two records of "update occlusion alarm" were found in the event history log.The investigator ran the pump with both standard and high follow sets and occlusion test.No issue were found.The pump operated as intended.The pump was calibrated and subsequently passed all the functional tests.

Event Description

It was reported that the pump's upstream occlusion alarm failed to clear during testing.No patient injury or complications were reported in relation to this event.

• Brand Name: CADD SOLIS VIP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 3350 granada avenue north; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10040391
• MDR Text Key: 190379829
• Report Number: 3012307300-2020-04222
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586042829
• UDI-Public: 10610586042829
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2020

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: No Information
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0102-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1