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

Model Number 2110

Device Problems Defective Alarm (1014); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported the device didn't administer medication for five hours.The disposable was not fully spiked so no medication could enter the tubing.However, the pump never alarmed for air or for a proximal occlusion.No adverse patient effects were reported by the customer.

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.

• 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: 17916459
• MDR Text Key: 326255594
• Report Number: 3012307300-2023-09619
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517154993
• UDI-Public: 15019517154993
• 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
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• 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: 21-2112-0402-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1