MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number HL-90-INT-230

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Electric Shock (2554)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that during use an electric leakage occurred in the clamp of the device resulting in an electric shock to the clinician.Clinician fainted from the shock and was hospitalized for two days following the event and is reported to be in good condition.No permanent injury resulted from this event.

Manufacturer Narrative

The suspect fluid warming device was returned for inspection.Visual inspection observed orange and green stains around the device that are indicative of fluid ingression.Before running the device, the device's water tank was filled with water.Water began leaking out and around the water tank cover.The water tank cover and its gaskets were replaced.After cover and gasket replacements, the tank was refilled with water.No leaks were immediately detected.Power was applied to the device; upon device start-up, water was immediately found leaking at the administration set output, and pooling close to the device's power source.As water is a conductor of electricity, the device was deemed unsafe to investigate while running.Further inspection of the device (while turned off) was performed.The o-rings in the unit were found hard and dried out preventing their intended water tight seal.Additionally, the power switch was found unseated from its intended location.The device's overall appearance suggests the unit has been lacking routine maintenance.Investigation could not definitely determine the exact root cause of the reported issue; however, investigation did not confirm it was related to a manufacturing issue.The device will be scapped.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 160 weymouth street; rockland MA 02370
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5297354
• MDR Text Key: 33489022
• Report Number: 2183502-2015-00972
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2012
• 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): Hospitalization; Other