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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. LEVEL 1 FLUID WARMER; SYSTEM, THERMAL REGULATING Back to Search Results
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.
 
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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 Key11008866
MDR Text Key221452406
Report Number3012307300-2020-19953
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeTC
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberL1-CW-220V
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received08/03/2022
Supplement Dates FDA Received09/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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