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); Pumping Stopped (1503)

Patient Problem Hypothermia (1915)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

A technical support engineer with the company organized a meeting with the customer on 26-nov-2020 in an attempt to trouble shoot the reported product problem.The support engineer noted that the occlusion/maintenance alarm was activated when the hose was disconnected from the unit.This was also reported by the customer.The support engineer noted further that this was an expected outcome that is outlined in the instructions for use (ifu) for the device.In addition to the above, the support engineer also discovered a secondary problem that was not reported by the customer.When the device was operated in the ambient state (i.E.When the unit blows ambient air into the blanket) an occlusion alarm was produced.This was a fault that should not have occurred.The evaluation of the affected device at the investigation site is still pending.A supplemental report will be sent after the device evaluation is completed.

Manufacturer Narrative

Other, other text: b5: updated with additional information.

Event Description

A technical support engineer with the company organized a meeting with the customer on (b)(6) 2020 in an attempt to trouble shoot the reported product problem.The support engineer noted that the occlusion/maintenance alarm was activated when the hose was disconnected from the unit.This was also reported by the customer.The support engineer noted further that this was an expected outcome that is outlined in the instructions for use (ifu) for the device.In addition to the above, the support engineer also discovered a secondary problem that was not reported by the customer.When the device was operated in the ambient state (i.E.When the unit blows ambient air into the blanket) an occlusion alarm was produced.This was a fault that should not have occurred.The evaluation of the affected device at the investigation site is still pending.A supplemental report will be sent after the device evaluation is completed.

• 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
• MDR Report Key: 11008887
• MDR Text Key: 221452427
• Report Number: 3012307300-2020-19951
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2021

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: 12/15/2020
• Supplement Dates Manufacturer Received: 01/29/2021; 01/29/2021
• Supplement Dates FDA Received: 02/27/2021; 02/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other