MAUDE Adverse Event Report: ST PAUL LEVEL 1; FLUID WARMER

Model Number 1200

Device Problems No Audible Alarm (1019); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2020

Event Type  malfunction  

Event Description

Information received a smiths medical fluid warming|level 1 trauma fast flow systems - h-1200 was not pumping and no alarm.No patient involvement, as event occurred during testing.

Manufacturer Narrative

Device evaluation- the device was returned for evaluation.The device was powered on and no fluid recirculated.The device was given internal examination; this showed the fluid return tube was cracked.The cracking condition had allowed for fluid to leak and damage multiple internal components.The damage to these components had caused the device to stop pumping.The cause of the cracking was not established.

• Brand Name: LEVEL 1
• Type of Device: FLUID WARMER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11128592
• MDR Text Key: 225487356
• Report Number: 3012307300-2021-00159
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• Combination Product (y/n): N
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1200
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1