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

Model Number 21-2120-0105-01

Device Problem Inaccurate Delivery (2339)

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

Event Type  malfunction  

Event Description

It was reported the pump delivered too slowly.No patient injury reported.

Manufacturer Narrative

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Date of event is unknown, no information has been provided to date.D10, h3 and h6 - evaluation codes: updated device evaluation: one device was returned for investigation.Tamper seal was not broken or removed.Visual inspection found the device was in good condition.Functional testing was not able to duplicate or confirm the complaint.A worn valve would eventually cause over delivery.A gauge was also used to measure the air detector height, as it could potentially restrict the flow rate of the device.The air detector failed the height test.The most probable cause for delivering too slow would be a programing issue.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.Replaced valves and air detector.

• Brand Name: CADD SOLIS VIP PUMPS
• 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: 16827978
• MDR Text Key: 314168274
• Report Number: 3012307300-2023-04675
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

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: Other
• Device Model Number: 21-2120-0105-01
• Device Catalogue Number: 21-2120-0105-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1