MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Complete Loss of Power (4015)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One hotline® blood and fluid warmer was returned for analysis.The enclosure, front cover, and line cord were observed to be damaged upon visual inspection.The unit was functional tested by filling the tank with water, attached the temp check, plugged in line cord, and turned on power switch; no power noted.Based on the evidence, the complaint was confirmed.The root cause was found due to a faulty pcb.

Event Description

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

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, mn ; 3833310
• MDR Report Key: 9908305
• MDR Text Key: 185901352
• Report Number: 3012307300-2020-02642
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2018
• 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