MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS

Catalog Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Tissue Damage (2104); Cardiogenic Shock (2262); Skin Tears (2516)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that some of the skin came off of a deceased patient when removing the arctic sun gel pads.A male patient in the medical intensive care unit was placed on an arctic sun device after a percutaneous coronary intervention (pci) with impella support.Arctic sun therapy was started on (b)(6) 2019 at 1857.The patient¿s temperature at the start of therapy was 89.6f with a target temperature goal of 92f-94f.The baseline skin assessment was described as intact.A large set of pads were used on the chest/abdomen and bilateral thighs.Nothing was applied to the skin prior to pad placement; however, the patient had received a bath prior to the pci procedure with sage blue bath wipes.During arctic sun therapy, the patient was receiving high doses of vasopressors, including vasopressin, levophed and epinephrine.The nurse reported that skin checks were not completed after application.The patient expired while receiving therapy on (b)(6) 2019 at 1232 approximately 17 hours after initiation of therapy.The nurse reported that the cause of death listed in the medical record was cardiogenic shock.A few minutes after the patient expired, the nurse removed the pad from the chest/abdomen and a thin layer of skin came off.There was no blister and the area did not involve a bony prominence or surgical incision.

Manufacturer Narrative

The reported event was confirmed as use related.The device was not returned for evaluation.The device was being used for treatment at the time of the reported event.The failure mode is '4.1 poor pad maintenance¿ with the root causes of '4.1.2 inadequate monitoring of skin condition under pad and 4.1.3 use of steroid or high dose vasopressor therapy.¿the lot number is unknown; therefore, a device history record could not be reviewed.A labeling review is not required.The product code is unknown.Therefore, bd is unable to determine the associated labeling to review.H11:section a through f - the information provided by bd represents all of 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 device was not returned.

Event Description

It was reported that some of the skin came off of a deceased patient when removing the arctic sun gel pads.A male patient in the medical intensive care unit was placed on an arctic sun device after a percutaneous coronary intervention (pci) with impella support.Arctic sun therapy was started on (b)(6), 2019 at 1857.The patient¿s temperature at the start of therapy was 89.6f with a target temperature goal of 92f-94f.The baseline skin assessment was described as intact.A large set of pads were used on the chest/abdomen and bilateral thighs.Nothing was applied to the skin prior to pad placement; however, the patient had received a bath prior to the pci procedure with sage blue bath wipes.During arctic sun therapy, the patient was receiving high doses of vasopressors, including vasopressin, levophed and epinephrine.The nurse reported that skin checks were not completed after application.The patient expired while receiving therapy on (b)(6) 2019 at 1232 approximately 17 hours after initiation of therapy.The nurse reported that the cause of death listed in the medical record was cardiogenic shock.A few minutes after the patient expired, the nurse removed the pad from the chest/abdomen and a thin layer of skin came off.There was no blister and the area did not involve a bony prominence or surgical incision.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9437886
• MDR Text Key: 178588249
• Report Number: 1018233-2019-07816
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other