MAUDE Adverse Event Report: ST PAUL LEVEL 1 TRAUMA FAST FLOW SYSTEMS; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number 8002950

Device Problems Display or Visual Feedback Problem (1184); Failure to Pump (1502)

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

Event Type  malfunction  

Event Description

It was reported that the device was not pumping or warming and sometimes the display was not showing.The issue was discovered during testing.

Manufacturer Narrative

Other text: no causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found device in good condition with no physical damage.Functional testing found device was not recirculating water.Removed back panel for further investigation.Visual inspection and found that there was a crack in the return tube which had leaked water, and damaged multiple internal components.Replaced main printed circuit board (pcb), return tube, and membrane switch.Device passed all functional and electrical tests.The root cause of the reported issue was found to be a design issue.An internal capa has been opened and this issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.

• Brand Name: LEVEL 1 TRAUMA FAST FLOW SYSTEMS
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• 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; minneapolis, MN 55442
• MDR Report Key: 12342675
• MDR Text Key: 267277770
• Report Number: 3012307300-2021-08608
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8002950
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1