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

Model Number 2110

Device Problem Calibration Problem (2890)

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

Event Type  malfunction  

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.

Event Description

It was reported that the device had failed calibration.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to a previous repair.Visual inspection found the device in good condition; however, the tamper seals were missing.There was no evidence of the error in the event history log.The reported problem was duplicated by calibration test.The investigation showed that the downstream occlusion sensor was inoperable and was also the cause of the reported problem.It was recommended replacing the downstream occlusion sensor as corrective action.The root cause of reported problem was unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Review of the device history record showed that there was no evidence of any issues during the manufacture of this device and there was no indication of a manufacturing defect during the investigation.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; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 11130 strang line rd; minneapolis, MN 55442
• MDR Report Key: 15532169
• MDR Text Key: 306351233
• Report Number: 3012307300-2022-20691
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• UDI-Public: 15019517154290
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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: 2110
• Device Catalogue Number: 21-2111-0402-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1