MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE 3 BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical level 1 hotline 3 blood and fluid warmer would not power on.There were no reported adverse effects.

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.Visual inspection revealed that the float switch was stained red, the enclosure was cracking by the drain fitting, both the covers were cracked, and the line cord was worn.The investigator subsequently filled the tank with water, attached a temperature fixture, plugged in the line cord, and turned on the power switch.The customer reported product problem (failure to power on) was confirmed during testing.The product problem occurred because of a defective component in the micro switch.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.A root cause was not established.The micro switch was replaced in order to correct the reported product problem.

• Brand Name: LEVEL 1 HOTLINE 3 BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10171062
• MDR Text Key: 195650628
• Report Number: 3012307300-2020-06056
• 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: 09/02/2020

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: No Information
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1