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

Model Number 2110

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Type  malfunction  

Manufacturer Narrative

Other text: 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.B3: unknown.

Event Description

It was reported the device over dispenses.Per reporter the device needs calibration.Patient involvement is unknown.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other text: additional information was received, there was no patient involvement.One device was received for evaluation.Visual inspection found the tamper seal to be broken, a scratched lens, and a peeling dso seal.There was no evidence to review in the device's event history log.To conduct functional testing, three accuracy tests were performed.Upon review, the device was found to be over delivering to the manufacturing specifications.It was determined that the expulsor was the root cause and replaced.The service history review identified no indication that the complaint was related to a service of the device within the review period.H6: health effects updated.

• Brand Name: CADD SOLIS HPCA
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17839058
• MDR Text Key: 324574367
• Report Number: 3012307300-2023-09351
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• 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
• Report Date: 11/02/2023

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: 21-2111-0300-01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1