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 08/04/2020

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.

Manufacturer Narrative

Corrected data: b3: additional information was received, stating that the correct event date of the reported event was (b)(6) 2020.

Manufacturer Narrative

H6.Device evaluation: a uk technical support engineer organized a meeting with the customer on (b)(6) 2020 in attempts to trouble shoot the issue.The customer reported reason was related to the occlusion led and maintenance led on.The patient received hypothermia.The device stopped warming and continued to alarm.During the call, a device (serial # unknown) was tested.The device was plugged in and it past post.When 37 was selected, the occlusion alarm came on.This confirmed the occlusion alarm but not the addition of the maintenance alarm.A 2nd test was performed by disconnecting the hose prior to start-up.The maintenance led and occlusion led did light up but this is as expected per the ifu.This replicated the customer reported reason but it was not determined if this was the same experience the customer had.A 3rd test was performed by selecting the ambient button.Again, the occlusion led came on but not the maintenance alarm.The device did not function as intended since the occlusion led was on during ambient and 37 degrees.The device did function as intended with the appropriate alarms (occlusion and maintenance) when the hose was disconnected from the device.During the call, the customer reported reason was confirmed and a secondary issue was found.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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): NULL; 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: 11011161
• MDR Text Key: 221506253
• Report Number: 3012307300-2020-12395
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

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 Number: L1-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 Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/25/2021; 07/24/2022
• Supplement Dates FDA Received: 02/23/2021; 09/20/2022
• 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