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

Model Number L1-CW-220V

Device Problems Device Alarm System (1012); Insufficient Heating (1287); Pumping Stopped (1503)

Patient Problem Hypothermia (1915)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Foreign: (b)(6).

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.

Manufacturer Narrative

A technical support engineer spoke with the customer to attempt troubleshooting the warming device.During the call, the device was plugged in and when 37 degrees centigrade was selected, the occlusion alarm came on which confirmed the report from the user.A second test was performed by disconnecting the power and the hose mechanically and electronically.Following the power was reconnected and the maintenance light-emitting diode (led) and occlusion led lit up as expected since the hose and thermistor cable were not properly connected.The hose was reconnected completely along with the power, and the standby light came on.Next the ambient button was pressed so only the blower would be active and within moments, the occlusion alarm light came on.Following the power was disconnected along with the mechanical hose.The thermistor cable was kept connected.The power was reconnected, and the standby light came on.The ambient button was pressed so that the blower would be active and in moments, the occlusion alarm light came on.As the hose was not in any way mechanically connected, the hose could not provide any obstruction to flow of air.Based on the above, it was concluded that the warming unit was at fault.The device was received to perform an investigation.A review of the event history log (ehl) identified error codes in the history.Functional testing was done on the received warming device and the reported problem was duplicated.The cause of this issue was a full filter as it was not changed on time.The filter was replaced to resolve the problem.In addition, the hose elbow and sheet clip were replaced.A device history record (dhr) review was unable to be performed as it was held by the supplier.D5 and g5 are unknown.No information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: LEVEL 1 FLUID WARMER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 11008866
• MDR Text Key: 221452406
• Report Number: 3012307300-2020-19953
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: TC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: L1-CW-220V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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