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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS; ARCTIC GEL PAD
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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS; ARCTIC GEL PAD Back to Search Results
Catalog Number 318-02-02
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Necrosis (1971)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be '8.2 bio-incompatible- effect 2: reaction¿ with a potential root cause of '8.2.2 materials that are contacting the patient's intact skin are not biocompatible.¿ the lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "the arctic sun temperature management system is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.Contraindications there are no known contraindications for the use of a non-invasive thermoregulatory system.Do not place the neonatal arctic gel pad on skin that has signs of ulcerations, burns, hives or rash.Do not remove the fabric release i=liner of the neonatal arctic gel pad and expose the hydrogel.Do not place the neonatal arctic gel pad hydrogel on immature (non-keratinized_ skin or premature babies.While there are no known allergies to hydrogel materials, caution should be exercised with any patient with a history of skin allergies or sensitivities.".
 
Event Description
It was reported that the infant on the arctic sun device developed fat necrosis.
 
Event Description
It was reported that the infant on the arctic sun device developed fat necrosis.Per additional information received on 18sep2019, the patient had some redness under one arm (triceps area) and the doctor suspected it could or could not be fat necrosis and that the area would go away on its own without intervention.The neonatal intensive care nurse described the area as red initially but now healed and resolved without intervention.The patient was one hour and 32 minutes old when therapy was initiated and 4.5 days old when therapy was stopped.A thin, light blanket was used in between the patient and the pad during therapy.
 
Manufacturer Narrative
The reported event was inconclusive based on the case photos.There is no evidence to link the sample to the event.The pdf labeled "8-3-19 hie patient debrief¿ shows the arctic sun control panel.The average water temperature temp throughout therapy was 36.3c.A potential failure mode could be '8.2 bio-incompatible- effect 2: reaction¿ with a potential root cause of '8.2.2 materials that are contacting the patient's intact skin are not biocompatible.¿ 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: "directions 1.Place the patient (1.8 - 4.5 kg; 4.0 - 9.9 lb) on the pad.Avoid placing the patients over the manifolds or other high pressure locations.The rate of temperature change and potentially the final achievable temperature is affected by pad surface area coverage, placement, patient size, and water temperature range.2.The pad surface must be contacting the skin for optimal energy transfer efficiency.A) if desired, the center section of the pad can be wrapped around the patient¿s torso and secured in place using the velcro tabs provided.¿ if this option is in use, ensure that the edges of the pad are away from articulating areas of the body to avoid irritation.¿ place pads to allow for full respiratory excursion.(e.G.Ensure free movement of the chest and abdomen are guaranteed).¿ the pads may be removed and reapplied if necessary.¿ pads should be placed on healthy, clean skin only.3.Due to the small patient size (1.8 - 4.5 kg; 4.0 - 9.9 lb) and the potential for rapid patient temperature change, it is recommended to use the following settings to the arctic sun® temperature management system: ¿ water temperature high limit: =40°c (104°f) ¿ water temperature low limit: =10°c (50°f) ¿ control strategy: 2 4.Due to the small patient size (1.8 - 4.5 kg; 4.0 - 9.9 lb) it is recommended to use the patient temperature high and patient temperature low alert settings.5.Place a core patient temperature probe and connect to the arctic sun® temperature management system patient temperature 1 connector for continuous patient temperature feedback.A rectal or esophageal temperature probe is recommended.6.Verify patient core temperature with an independent temperature probe before and at regular intervals during use.7.Attach the pad¿s line connectors to the fluid delivery line manifolds.8.See arctic sun® temperature management system operators manual and help screens for detailed instructions on system use.9.Begin treating the patient.10.If the pad fails to prime or a significant continuous air leak is observed in the pad return line, check the connections, then if needed, replace the leaking pad.Once the pad is primed, assure the steady state flow rate displayed on the control panel is appropriate.The minimum flow rate should be 1.1 l/m.11.When finished, purge water from pad." correction: d4.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.
 
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 infant on the arctic sun device developed fat necrosis.Per additional information received on 18sep2019, the patient had some redness under one arm (triceps area) and the doctor suspected it could or could not be fat necrosis and that the area would go away on its own without intervention.The neonatal intensive care nurse described the area as red initially but now healed and resolved without intervention.The patient was one hour and 32 minutes old when therapy was initiated and 4.5 days old when therapy was stopped.A thin, light blanket was used in between the patient and the pad during therapy.
 
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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 Key9008529
MDR Text Key161736079
Report Number1018233-2019-05598
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2019
Device Catalogue Number318-02-02
Device Lot NumberNGCX2370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Date Manufacturer Received10/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age5 DA
Patient Weight3
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