MAUDE Adverse Event Report: ST PAUL CADD SOLIS PUMP; PUMP, INFUSION, PCA

Model Number 2110

Device Problems Incorrect Measurement (1383); Improper Flow or Infusion (2954)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received indicating that the pump was failing accuracy testing.

Manufacturer Narrative

Other, other text: d5: unknown.E4: unknown.H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The tamper seal was missing.The event log showed no evidence of the reported problem.Upon function testing, the reported problem was duplicated.The expulsor was over delivering.The root cause of the reported problem is unknown.The expulsor was replaced to resolve the issue.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 reported problem during the review of service and repair records.Therefore, no manufacturing or service records review is needed.

• Brand Name: CADD SOLIS PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14063578
• MDR Text Key: 288999525
• Report Number: 3012307300-2022-06069
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038808
• UDI-Public: 10610586038808
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130394
• 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,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2110
• Device Catalogue Number: 21-2112-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1