MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS VIP PUMPS; PUMP, INFUSION

Model Number 2120

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Device Contamination with Body Fluid (2317); Pressure Problem (3012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Operator of device is unknown; no further information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported medication leaked on the pump.No patient injury reported.

Manufacturer Narrative

Additional information received on 07mar2023 via email and attached to complaint: there was a leak via the pump on (b)(6) 2022.It's reverse effect, not infusion from pump to patient.Instead, the iv tubing configured to return blood and medication from central line to pump.It infused backwards.In iv tubing, it appears to cause negative pressure.Event date changed from unknown to (b)(6) 2022.Patient details not provided.No additional information available.

Manufacturer Narrative

Corrected data: health effects - clinical signs and symptoms or conditions corrected.

• Brand Name: CADD SOLIS VIP PUMPS
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; mrsd scvhhs receiving dock; minneapolis, MN 55442
• MDR Report Key: 16467181
• MDR Text Key: 310508737
• Report Number: 3012307300-2023-01874
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517126587
• UDI-Public: 15019517126587
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0104-01
• 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: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1