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

Model Number 2110

Device Problems Improper Flow or Infusion (2954); Application Program Problem: Medication Error (3198)

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

Event Type  malfunction  

Event Description

It was reported that the pump exhibited new software upgrade functional and operational issues whereby more medication was discharged than requested during testing.No patient involvement was reported.

Manufacturer Narrative

No information has been provided to date.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, other text: h6: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The device was found to be missing the tamper seal.The event log showed no evidence of the reported problem.Upon function testing, the reported problem could not be duplicated as the device operated as intended.The root cause of the reported problem is unknown.The software was reinstalled as a preventative measure.A manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture or last repair of the device.No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.Therefore, no manufacturing or service records review is needed.

• Brand Name: CADD SOLIS AMBULATORY INFUSION PUMP WITH WIRELESS
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15297102
• MDR Text Key: 303239891
• Report Number: 3012307300-2022-16258
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517154993
• UDI-Public: 15019517154993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2110
• Device Catalogue Number: 21-2112-0402-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1