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

Catalog Number 317-02

Device Problem Nonstandard Device (1420)

Patient Problems Rash (2033); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)

Event Date 05/09/2021

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 arctic gel pad was extremely sticky, hence patient experienced skin redness and irritation where the pads were placed.It took 15mins for 2 nurses to take off the gel pads.Per troubleshooting, user tried to put neonatal or child pad under torso which helped for a couple of hours.But as there was no enough surface area, the pads were reapplied during the night.On 10may21, the pads were again removed and were found to be extremely sticky with skin redness and irritation.It was also noted that there was no skin breakdown and skin was no longer irritated after 2 days off.No medical intervention was reported.Per follow up on 03jun2021, customer stated nothing out of the ordinary as the condition of skin before the pads were applied and it was opened up from a new package.Chg treatment was applied at some point in the day before going on pads as it¿s part of our usual practice for daily treatments.It was not applied right before pad placement and no lotions were used.In bilateral abdomen or sides of torso and upper thighs reddened were located.It looked like the skin was discolored, blistered, scabbed, rash, red, skin irritation.No treatment or wound or skin consult conducted.Customer checked skin were intermittently done, but did not occur more frequently than q8 hours.Patient had no comorbidities that contributed to the patient¿s skin condition.The pads were not placed over any incision or bony surfaces.Patient tried to use neonatal or pediatric pad rather than put the xs adult pads back on, however, that only worked for a period of time and was able to try new set of pads and use at a later time, though they were very sticky as well.No medical intervention was reported.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential root cause could be due to "material selection - surface roughness, adhesive strength".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: ''1.Arcticgel¿ pads are only for use with an arctic sun® temperature management system control module.See operators manual for detailed instructions on system use.2.Select the proper number, size and style pad for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the entire pad set (4).If the entire set of pads is not used, the minimum flow rate may not be achieved.3.For patient comfort, the pads may be prewarmed using water temperature control mode (manual) prior to application.4.Place the pads on healthy, clean skin only.Remove any creams or lotions from patient¿s skin before pad application.Remove the release liner from each pad and apply to the appropriate area.The pads may be overlapped or folded adhesive-to-adhesive to achieve proper placement.The pads may be removed and reapplied if necessary.The pad surface must be contacting the skin for optimal energy transfer efficiency.Place pads to allow for full respiratory excursion.5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4).7.When finished, empty water from pads.Cold temperature increases the adhesiveness of the hydrogel.For ease of removal, leave pads on the patient for approximately 15 minutes to allow the hydrogel to warm.Slowly remove pads from the patient and discard".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 device was not returned.

Event Description

It was reported that the arctic gel pad was extremely sticky, hence patient experienced skin redness and irritation where the pads were placed.It took 15mins for 2 nurses to take off the gel pads.Per troubleshooting, user tried to put neonatal or child pad under torso which helped for a couple of hours.But as there was no enough surface area, the pads were reapplied during the night.On 10may21, the pads were again removed and were found to be extremely sticky with skin redness and irritation.It was also noted that there was no skin breakdown and skin was no longer irritated after 2 days off.No medical intervention was reported.Per follow up on 03jun2021, customer stated nothing out of the ordinary as the condition of skin before the pads were applied and it was opened up from a new package.Chg treatment was applied at some point in the day before going on pads as it¿s part of our usual practice for daily treatments.It was not applied right before pad placement and no lotions were used.In bilateral abdomen or sides of torso and upper thighs reddened were located.It looked like the skin was discolored, blistered, scabbed, rash, red, skin irritation.No treatment or wound or skin consult conducted.Customer checked skin were intermittently done, but did not occur more frequently than q8 hours.Patient had no comorbidities that contributed to the patient¿s skin condition.The pads were not placed over any incision or bony surfaces.Patient tried to use neonatal or pediatric pad rather than put the xs adult pads back on, however, that only worked for a period of time and was able to try new set of pads and use at a later time, though they were very sticky as well.No medical intervention was reported.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
• Type of Device: ARCTICGEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 12099889
• MDR Text Key: 259398231
• Report Number: 1018233-2021-03967
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other