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

Model Number 2110

Device Problems Device Alarm System (1012); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.B3 unknown, d3, g1, and g2 email is:(b)(6).

Event Description

It was reported that the pump alarmed continuously and would not power off and on.It is unknown if there was patient involvement, no adverse patient effects were reported.

Manufacturer Narrative

One device was returned for analysis.Visual inspection showed a cracked dso seal, worn uso seal, and scratched lens.The pump did not power on.The tamper seal was broken.The ehl was unable to be downloaded.A functional test was performed and the reported issue was duplicated.When powering up, the device displayed a constant alarm.The cause was due to the pwa board.As a result, the pwa board was replaced.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.Email is: (b)(6).

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 18292320
• MDR Text Key: 330057027
• Report Number: 3012307300-2023-10992
• Device Sequence Number: 1
• Product Code: MEA
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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: 21-2111-0100-51
• 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: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1