MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FLUID WARMER; THERMAL REGULATING THERMAL REGULATING SYSTEM

Model Number L1-CW-220V

Device Problems Device Alarm System (1012); Pumping Stopped (1503)

Patient Problem Hypothermia (1915)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical heater automatically switched off when in used.The occlusion and service indication alarms went off.They reset the device per the manual but still the alarms remained.The device stopped warming and kept alarming.The patient got hypothermia as a result.No other adverse events reported.

• Brand Name: LEVEL 1 FLUID WARMER
• Type of Device: THERMAL REGULATING THERMAL REGULATING SYSTEM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; prime tower, business bay, p o; minneapolis, MN 55442
• MDR Report Key: 11003113
• MDR Text Key: 221271357
• Report Number: 3012307300-2020-12343
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: AE
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: L1-CW-220V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2019
• 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
• Patient Outcome(s): Other