MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS VIP 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 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

E1: phone (b)(6) a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the device exhibited an air in line alarm, three hours before the end time of the infusion (8:47am).The patient missed 9.5 ml of medicine.When checking the pca pump, there would still be 14.5 ml of medicine left in the tank, and according to the medication instructions, the change time would only be when there is 5 ml left in the pump.Small amounts of air can be seen in the tubing of the medicine cartridge.Infusion started 28.12.-23 according to the pump at 11:46.The medication in the medication cartridge has apparently been administered faster than the pump has been programmed.No adverse patient effects were reported by the customer.Per reporter the infusion was for a 96-hr blincyto drug infusion.

Manufacturer Narrative

One device was returned for evaluation.Visual inspection revealed the entire device slightly worn, battery compartment and battery door damaged, the downstream occlusion (dso), battery door, battery compartment, remote does connector and ac adapter connector showed signs of fluid ingression, and the dso gasket had an air bubble.The event history log confirmed ¿downstream occlusion¿ alarm messages occurred.The event history log also showed that the pump volume was set to 250ml and the continuous rate to 2.5ml/hr.Functional testing was able to replicate the reported issue; the device flow rate was found to be slightly too low.The root cause was determined to be the expulsor.The expulsor was replaced.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• 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: 18913373
• MDR Text Key: 337772885
• Report Number: 3012307300-2024-01413
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: 21-2120-0105-15L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/29/2024
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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
• Treatment: BLINCYTO.