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

Model Number 2120

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: unknown.One device was received for evaluation.Visual inspection found a damaged dso seal, damaged battery compartment, and a damaged lcd display.There was no evidence in the event history log.Functional testing was unable to verify or duplicate the reported problem; however, visual inspection revealed the damaged dso seal.The dso seal, battery compartment, and lcd display were replaced.The service history review identified no indication that the complaint was related to a service of the device within the review period.

Event Description

It was stated that pump won't turn on.There was unknown patient involvement.

• Brand Name: CADD SOLIS VIP PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19080929
• MDR Text Key: 340241912
• Report Number: 3012307300-2024-02342
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586042591
• UDI-Public: 10610586042591
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0102-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1