MAUDE Adverse Event Report: ST PAUL CADD SOLIS VIP PUMPS ? 2120; PUMP, INFUSION

Model Number 21-2120-0105-01

Device Problems Failure to Deliver (2338); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2021

Event Type  malfunction  

Event Description

Information was received regarding a cadd solis vip pump.It was reported that reporter went home to assist with bag change, and when he removed the abt from the bag he noted the bag was full.He stated a green light was blinking and the reservoir volume was at 20.4mls.The pump program was reviewed for ampicillin 8gm in 580mls ns with a continuous rate of 24.2mls/hr and reservoir volume of 20.4mls.They reviewed the event log and noted that the pump was started at 10:35am and he did not note any alarms in the event log throughout the evening.Patient had been off abt for a little under 24 hours.They were advised to stop the pump and disconnect the patient, as abt is only good for 24 hours.They were also advised to follow up with the rph to request a new pre-programmed pump and delivery asap.It is unknown if there was no patient, or clinician injury associated with this event.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customers reported problem were found during the review of the service and repair records.A product sample was received for evaluation.Visual inspection showed tampered seal label was missing, device in good condition.During functional check, the reported complaint was duplicated.Running three accuracy tests, and at least one was found to be under delivering as per manufacturing specifications.The exact root cause is unknown.However, the expulsor was replaced.

• Brand Name: CADD SOLIS VIP PUMPS ? 2120
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13048068
• MDR Text Key: 282563205
• Report Number: 3012307300-2021-13043
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517150001
• UDI-Public: 15019517150001
• Combination Product (y/n): N
• PMA/PMN Number: K111275
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-2120-0105-01
• Device Catalogue Number: 21-2120-0105-01
• 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: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female