MAUDE Adverse Event Report: ST PAUL LEVEL 1 FLUID WARMING SYSTEM; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number H-1200

Device Problem Pumping Problem (3016)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the pump on the level 1 trauma fast flow system (h-1200) was not working.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A device history report (dhr) review was not applicable in this case because the defective component is not evaluated or tested in any way during the manufacturing process at this manufacturing site and the device manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.A product sample was received for evaluation.Visual and functional testing were performed.Received device in good condition with no physical damage.The technician filled water into reservoir tank, installed temperature check, installed f-30 gas vent filter onto air detector, which attached to filter holder interlock switch.The reported problem was confirmed by the technician.The root cause of the reported problem was found to be cracked return tube due to the design.The technician replaced main printer circuit board (pcb).

• Brand Name: LEVEL 1 FLUID WARMING SYSTEM
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11873460
• MDR Text Key: 252299207
• Report Number: 3012307300-2021-04936
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H-1200
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1