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

Model Number 2120

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Type  malfunction  

Event Description

It was reported that the pump was found to be over infusing during annual testing.It is running at 30ml/hr for 10ml.

Manufacturer Narrative

Other text: b3: date of event, d4:udi section is unknown.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 reportable information becomes available.

Manufacturer Narrative

Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: one device was received.A visual inspection found the device in good condition apart from the worn dso seal.During the functional testing, the customer reported problem was duplicated during the accuracy test.The cause of the over delivery is unknown.The expulsor and valves were replaced.Product is beyond one year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.Service history review identified this device has not been in for service previously.

• Brand Name: CADD SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• 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: 17418663
• MDR Text Key: 320163160
• Report Number: 3012307300-2023-07559
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• 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: 21-2112-0300-50
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1