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

Model Number 2120

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: unknown.One device was received for evaluation.Visual inspection found the tamper seal to be broken.Functional testing was able to verify and duplicate the reported issue.It was determined that the out of specification battery compartment was the root cause and 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 reported that the device's battery compartment was burnt.The product fault occurred during testing, there was no 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: 18996843
• MDR Text Key: 338915096
• Report Number: 3012307300-2024-01758
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517126587
• UDI-Public: 15019517126587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 21-2120-0104-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• 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