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

Model Number 2120

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: event date unknown.H3: device not received by manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

It was reported that the device exhibited an alarm for ¿delivery too slow¿.There was unknown patient involvement and unknown patient harm.

• Brand Name: CADD-SOLIS VIP AMBULATORY INFUSION 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19195623
• MDR Text Key: 341375114
• Report Number: 3012307300-2024-03095
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517150292
• UDI-Public: 15019517150292
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• 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: 21-2127-0105-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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