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

Model Number 2120

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that pump stopped three hours earlier than it was supposed to.11mls left in the bag, but pump read 0mls.There was usually overfill of about 9.2mls with the patient's blincyto pumps.Pump was programmed correctly but would not continue to infuse.The pumped alarmed and message says complete.There was a closed system transfer device used.The pump was used to prime the extension tubing.The patient was able to a new pump put on with no issues.Drug infused: blincyto.Volume to be infused: 100.8mls.Volume remaining: 11mls.Reservoir: 0mls, infusion rate: 0.6ml/hr.Air detector and upstream sensor were on.Length of infusion was 7 days pump.No adverse patient effects were reported by the customer.

Manufacturer Narrative

H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• 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: 18992885
• MDR Text Key: 338814209
• Report Number: 3012307300-2024-01787
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517150001
• UDI-Public: 15019517150001
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

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: Lay User/Patient
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0105-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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; CST; EXTENSION TUBING