MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-90); WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problems Failure to Sense (1559); Device Sensing Problem (2917)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the readings on the level 1 hotline low flow system (hl-90) display were fluctuating.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

H3: one level 1 hotline low flow system was received with an outdated printed circuit board (pcb), power switch, front cover and line cord.A visual inspection was conducted, the water tank was filled, the temperature check was attached, the line cord was plugged in and the device was turned on.The reported issue was able to be duplicated.The issue was caused by a faulty pump.No action will be taken to repair the device due to its age and condition.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-90)
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10370185
• MDR Text Key: 201771222
• Report Number: 3012307300-2020-07861
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1