MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PAD

Catalog Number 317-07

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the target temperature management case was started on (b)(6) 2021, for a severe traumatic brain injury (tbi) patient.The patient was treated with normothermia protocol with new medium sized arctic gel pads.On (b)(6) 2021, doctors found that the arctic gel pad layer had peeled away from all 4 gel pads on both legs and chest.The gel pads no longer had the ability to stick to the patient¿s skin, and it needs to be fixed with ties.The gel pads were stored at a room temperature of 20c to 24c in the storage.The gel pads were in good condition, with no signs of gel peeling prior to initiating therapy.The gel pads were not exposed to any liquids during patient care.It was mentioned that the patient temperature was difficult to control.

Manufacturer Narrative

The reported event was confirmed.The root cause was unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one medium arctic gel pad kit with no original packaging present.Visual inspection noted that the hydrogel layer was separated from the pad on the left chest, right chest, left thigh, right thigh on the return sample.A potential failure mode is "3.1 hydrogel peels away from film".A potential root cause for this failure could be "3.1.1 improper design consideration or material selection".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the neonatal arcticgel¿ pad is non-sterile for single patient use only.The water content of the hydrogel affects the pad¿s adhesion to the skin and conductivity, and therefore, the efficiency of controlling patient temperature.Periodically check that pads remain moist and adherent.Replace pads when the hydrogel no longer uniformly adheres to the skin.Replacing pads at least every 5 days is recommended".The actual/suspected device was inspected.

Event Description

It was reported that the target temperature management case was started on (b)(6) 2021, for a severe traumatic brain injury (tbi) patient.The patient was treated with normothermia protocol with new medium sized arctic gel pads.On (b)(6) 2021, doctors found that the arctic gel pad layer had peeled away from all 4 gel pads on both legs and chest.The gel pads no longer had the ability to stick to the patient¿s skin, and it needs to be fixed with ties.The gel pads were stored at a room temperature of 20c to 24c in the storage.The gel pads were in good condition, with no signs of gel peeling prior to initiating therapy.The gel pads were not exposed to any liquids during patient care.It was mentioned that the patient temperature was difficult to control.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13349458
• MDR Text Key: 285410583
• Report Number: 1018233-2022-00164
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 317-07
• Device Lot Number: NGFS2837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male