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

Model Number 2110

Device Problems Device Alarm System (1012); Pumping Stopped (1503)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

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 patient was sent home with 5-fluorouracil pump which was programmed to infuse 3700mg of drug over 46 hours; however, the pump started alarming and exhibited an error of ¿stop and remove¿.The patient presented to the hospital emergency room to have the pump removed.No adverse patient effects were reported.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• 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: 18860102
• MDR Text Key: 337299174
• Report Number: 3012307300-2024-01194
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517099690
• UDI-Public: 15019517099690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0401-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• 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
• Treatment: 5-FLUOROURACIL
• Patient Age: 51 YR
• Patient Sex: Male