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

Model Number HL-390

Device Problems Crack (1135); Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

One level 1 hotline 3 blood and fluid warmer was returned for analysis.The enclosure was observed to be scuffed and dirty upon visual inspection of the unit.The pole clamp was noted to damaged, drain fitting was rusted, tank cover was observed to be cracked and stained.The tank was filled with water, the line cord was plugged in and was switched to power on; confirming the complaint of no power to the device.Based on the evidence, the root cause was found due to a faulty pcb.

Event Description

Information was received indicating that there was no power to a smiths medical level 1 hotline 3 blood and fluid warmer.There were no reported adverse effects.

• 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
• 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: 10056003
• MDR Text Key: 190939758
• Report Number: 3012307300-2020-04417
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2011
• 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