MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE; SYSTEM, THERMAL REGULATING

Model Number EQ-5000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.(b)(4).

Event Description

It was reported that a level 1® equator® convective warming device was involved in an incident where the patient was found to have been burned during a surgical procedure.The patient was undergoing an electrocautery procedure on his back and the warming device was in use for approximately 100 minutes on the patient's lower body.The patient's diaper had been removed and a moltex absorbent pad was used between the patient and a competitor's warming blanket at his pelvis.The patient was placed on a combination gas (ultiva) for the procedure.It was initially reported that there was thermal damage of "grade 2a" at the cervical spine and anus and then it was clarified that the patient received level 2 burns and redness at the buttocks and thighs.The patient's temperature was measured via a nasal probe and monitored every 5 minutes; it was noted that the temperature was normal when the burn was noticed and normal after the warming blanket was used.Due to the incident, it was initially reported that the patient underwent a treatment protocol for 'diathermatitis' and then it was clarified that the protocol was for diaper rash and dressings were applied.The patient received intravenous fluids of "full e-lyt solution + 2% glucose via perfusor." it was reported that the patient was at increased risk of infection due to the additional pathway for infection; antibiotics for respiratory infection were prescribed.It was suspected that the equator had no damage and it was unknown what the cause of the "thermal defect" was.There was no alarm noted during the procedure.It was unknown when the warming device was last calibrated.The patient was reported to have skin changes due to healing and was in recovery.

Manufacturer Narrative

One level 1® equator® convective warming device was returned for investigation.The device was received with hose and power cord; it was noted that the hose did not have the device serial number written inside.The reported non-smiths medical blanket was not returned.Visual inspection revealed that the returned device was in good condition; dings and scratches were noted on the device case.The device filter was found to be in acceptable condition and was used for testing.During functional testing, the returned accessories were assembled and the warming device was turned on.The device performed its self-test with no issues observed.The device hose and thermistor disconnection alarms were then tested; the device passed both tests.The device was set to each of its three different temperature setting; all temperatures were found within specification.The device was tested at a 75% cold start and at 100% occlusion; the device passed both tests within manufacturing specification.The warming device was forced into over temperature at each temperature setting.During all three forced overheating simulations, the alarm sounded and the warming device shut itself off within temperature specifications.The device was set to each of its three temperature settings and allowed to run for 2 hours intervals.It was found that the device operated as intended without issue.The reported product problem could not be duplicated as the returned device and attachments operated in specification with no faults found.It was noted that the report stated that a non-smiths medical snuggle warm blanket was used during the procedure which is not permitted per the device instructions for use.Please note: according to the reporter, no one at the hospital was able to verify that the returned device was the actual device used in surgery as the serial numbers of the involved devices was not documented.It was believed that the returned device was involved in the incident; however, it could not be "100%" verified.

Event Description

It was further reported that the temperature setting during use was 40 degrees celsius.Additionally, no adaptors were used and no blanket issues were noted during surgery.

• Brand Name: LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 3350 granada avenue; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6216295
• MDR Text Key: 63666706
• Report Number: 3012307300-2016-00667
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: EQ-5000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• 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
• Treatment: MOECK & MOECK BABY/INFANT REUSABLE WARMING BLANKET
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 1 MO
• Patient Weight: 5