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

Catalog Number 317-07-02

Device Problems Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Skin Tears (2516); Blister (4537)

Event Date 11/22/2022

Event Type  Injury  

Event Description

It was reported that when using the bard hypothermia arctic gel pad, the patch failed and burned a patient, thus requiring medical intervention.As per follow up information received via email on 29nov2022, the patient received a 9cm x 9cm x 0.1 cm burn with unroofed blister.The patient condition before applying pads was supervised by representative or cardiac arrest and met criteria for targeted temperature management (ttm) and placed on therapy patient had no open areas or wounds prior to initiation of therapy.Thigh pad was discontinued due to injury, remaining pads and therapy discontinued one hour later with treatment goal met.Patient seen appropriate consults, therapy discontinued, wound treated by care consult.In critical care primary physician evaluation patient treated with pad removal, and discontinued area cleansed and silvadene applied followed by telfa and dressing pat with lot number # nggs2684.The date of event was on (b)(6) 2022.It was noted that the weight of the patient to be 67years old female with height 160cm (5'3") with weight 57.1 kg (125 lbs and 14oz).Faulty pad was saved.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was unconfirmed as no leakage occurred during sample evaluation.Visual evaluation noted received 1 arctic gel pad left thigh with no original packaging.Visual inspection of the pad surface noted no obvious visible defects such as cuts or tears in the foam.Visual inspection of the clear connectors noted no visible chips or deformities at the ends of all connectors.Visual inspection of the tubing for all the pads noted no kinks.Further testing required.Functional evaluation noted flow test was conducted.No leakage occurred during the duration of the test therefore product meets specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is not required as the reported event is unconfirmed.Correction: d, f, g, h.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that when using the bard hypothermia arctic gel pad, the patch failed and burned a patient, thus requiring medical intervention.Per follow-up information received via email on 29nov2022, the patient received a 9 cm x 9 cm x 0.1 cm burn with unroofed blister.The patient condition before applying pads was supervised by representative or cardiac arrest and met criteria for targeted temperature management (ttm) and placed on therapy patient had no open areas or wounds prior to initiation of therapy.Thigh pad was discontinued due to injury, remaining pads and therapy discontinued one hour later with treatment goal met.Patient seen appropriate consults, therapy discontinued, wound treated by care consult.In critical care primary physician evaluation, patient treated with pad removal, and discontinued area cleansed and silvadene applied followed by telfa and dressing pat with lot number # nggs2684.The date of event was on 22nov2022.It was noted that the weight of the patient to be 67 years old female with height 160 cm (5'3") with weight 57.1 kg (125 lbs and 14oz).Faulty pad was saved.Per additional information received via form with sample returned on 12dec2022, arctic gel on pad release from usual dot matrix into one patch.The patch then leaked water onto the patient thigh during the warming phase of target temperature management.Patient peeled surface or burn from patch area.Temperature set at 37.4c.The patient had injury to skin requiring treatment and wound consult.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTIC GEL PADS
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15958590
• MDR Text Key: 305248531
• Report Number: 1018233-2022-09452
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 317-07-02
• Device Lot Number: NGGS2684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 57 KG