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

Model Number	HL-390-40
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An unknown customer issue was reported for a life-sustaining device.
Additional Manufacturer Narrative
Additional information received at smiths medical 09-dec-2021: no product is returning, no product serial numbers provided.

• Brand Name: LEVEL 1
• Common Device Name: 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
• Report Number: 3012307300-2021-09953
• Device Sequence Number: 4343766
• Product Code: LGZ
• UDI-Device Identifier: 10695085002833
• UDI-Public: 10695085002833
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 06/14/2023
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 03/30/2022; 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown