MAUDE Adverse Event Report: ST PAUL LEVEL 1; INFUSION PUMP

Model Number HL-390-40

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/20/2021

Event Type  Injury  

Event Description

An unknown customer issue was reported for a life-sustaining device.

Manufacturer Narrative

Additional information received at smiths medical 09-dec-2021: no product is returning, no product serial numbers provided.

• Brand Name: LEVEL 1
• Type of Device: INFUSION PUMP
• 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; doctors park, #114; minneapolis, MN 55442
• MDR Report Key: 12628902
• MDR Text Key: 276354409
• Report Number: 3012307300-2021-09953
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002833
• UDI-Public: 10695085002833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-390-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention