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

Model Number 2120

Device Problems Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339); Improper Flow or Infusion (2954)

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

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: 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 under infused, yondelis 500 ml over 24 hours, 180ml remained.No patient injury reported.No additional information is available.

Manufacturer Narrative

Other text: h6: event methods, evaluation, and conclusion codes: updated.No product sample was received; therefore, visual and functional testing could not be performed.The investigation determined the most probable cause of the reported issue was a programming issue, but the reported issue could not be confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: CADD SOLIS VIP AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16786124
• MDR Text Key: 313741586
• Report Number: 3012307300-2023-04362
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1