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

Catalog Number 21-2120-0105-12L

Device Problem Defective Alarm (1014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No causes or potential causes of the customers reported problem were found during the review of the service and repair records.The device was received for evaluation.Visual inspection showed labels were undamaged, but display glass was scratched.Event history log shows downstream occlusion alarm messages.No disposable alarm testing ran as per procedure and device passed.The reported issue could not be duplicated.The pumps downstream occlusion sensor was tested.It was found to be functioning properly and activating within specification.Root cause is unknown.However, the downstream occlusion sensor was recalibrated as preventive measure.

Event Description

It was reported that the pumps frequently sound alarms for upward occlusion.The customer tested the pumps and there is no good explanation for the alarms.The alarm comes at intermittent bolus and only after second bolus.No patient injury reported.

• Brand Name: CADD SOLIS VIP PUMPS
• 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: jim vegel
• MDR Report Key: 16897027
• MDR Text Key: 314849332
• Report Number: 3012307300-2023-05407
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-2120-0105-12L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1