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

Model Number 2110

Device Problems Obstruction of Flow (2423); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Awaiting completion of device evaluation.

Event Description

It was reported that "device will not turn on with battery power or adapter attached.Also nursing staff reported that device was alarming for a downward occlusion when there was none present." patient involvement is unknown.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-05804.The report was submitted in error.

• Brand Name: CADD SOLIS INFUSION SYSTEM
• 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: 13998871
• MDR Text Key: 288601696
• Report Number: 3012307300-2022-05804
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

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?: No
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1