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

Device Problems Patient-Device Incompatibility (2682); Temperature Problem (3022)

Patient Problem Injury (2348)

Event Type  Injury  

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 patient received skin injuries on their back and thighs on the arctic sun device.Downloaded case and got information from cvicu manager.Patient was on crrt, and a blood warmer was not used so the water temperature of the arctic sun was at 40 celcius for an extended period of time.Explained to cvicu that a blood warmer needed to be used with crrt when used in conjuction with the arctic sun.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be '2.4 incorrect pad placement - effect ii: skin damage' with a potential root cause of '2.3.8 pad edges placed in articulating areas of the body.' the lot number is unknown therefore the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.Correction: d10, h3.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 the patient developed skin injuries on the back and bilateral thighs while receiving therapy on the arctic sun device.Therapy was initiated on (b)(6)2019 , post cardiac arrest.The patient was receiving continuous renal replacement therapy (crrt) concurrently, without the use of a blood warmer.The water temperature of the device remained at 40c for an extended period.A follow-up email was sent to nurse lauren, cardiovascular intensive care unit manager, on (b)(6)2020 who responded providing additional information.Nurse lauren stated the patient's skin was intact prior to application of the pads, but the skin was edematous.Documentation reflected the patient¿s temperature was 33.2c, target temperature was 33c, the flow rate was 3.2l/m and skin checks were completed every 4 hours.It is unknown when the skin injuries developed; however, a wound care nurse was consulted, and barrier treatment was applied.Nurse lauren also stated that after the patient completed arctic sun therapy on (b)(6)2019 , the family and medical team placed the patient on comfort care measures due to their condition.The patient expired shortly after being placed on comfort care.Nurse lauren could not confirm the cause or date of death and patient history is unknown at this time.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9565023
• MDR Text Key: 174179951
• Report Number: 1018233-2020-00182
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention