MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problems Pumping Problem (3016); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One level 1 hotline low flow system was received with the printed circuit board (pcb), power switch and retainer needing an upgrade.The pump was very noisy, the enclosure was cracked at the drain fitting causing a leak, both covers were cracked, the heater was defective, he microswitch was broken and the line cord was worn.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.Normal wear and tear caused the noisy pump.The pump was replaced to resolve the primary issue.

Event Description

Information was received indicating that a smiths medical level 1 hotline low flow system was making loud noises and the pump was failing.There was no reported adverse event.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11094828
• MDR Text Key: 224296153
• Report Number: 3012307300-2020-12848
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• 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
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1