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

Model Number 31705

Device Problem Inaccurate Flow Rate (1249)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

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 while using the arctic gel pad, the flow rate was about 0.3 to 0.4 l, and the alarm (air bubble detection) was sounding.Stated that the user was using 4 new s size pads, and confirmed that there were no abnormalities in the pad connections, bends, and overlaps.When the pad was replaced with another one, the flow rate was secured and it returned to normal operation.

Manufacturer Narrative

The reported event was confirmed and the cause was unknown.Visual evaluation of the returned sample noted one opened (original packaging present), small arctic gel pad kit present.All four pads were returned.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 obvious defects.A potential root cause for this failure was low flow due to over-lamination of foam to film due to temp controller set too high, belt speed controller set too low or failed, nip roller pressure regulator set too high, upper belt temperature is > 85 deg c.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 for use: 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 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 actual/suspected device was inspected.

Event Description

It was reported that while using the arctic gel pad, the flow rate was about 0.3 to 0.4 l, and the alarm (air bubble detection) was sounding.Stated that the user was using 4 new s size pads, and confirmed that there were no abnormalities in the pad connections, bends, and overlaps.When the pad was replaced with another one, the flow rate was secured and it returned to normal operation.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
• Type of Device: ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11344332
• MDR Text Key: 233034077
• Report Number: 1018233-2021-00636
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 31705
• Device Catalogue Number: 31705
• Device Lot Number: NGEN1810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other