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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 317-00
Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 patient was not heating on the arctic sun device.The patient was in cooling mode, but the pads felt warm and water temperature was at 40c.There was also a low flow alert (alert 02).Patient temperature was 33.7c and target was 36c.Ms&s explained that the device was trying to warm the patient up to target, and the pads should not feel cold if the patient was below target.Flow rate was 0.8lpm because the patient only had a universal pad on the their back because they did not have a small set of pads.Ms&s explained that a universal pad alone was not going to do anything.They had a large set of pads and ms&s advised that they could overlap as much as they needed to and use a full set rather than a single universal pad.Per follow up via phone on (b)(6) 2020 the nurse stated they changed the pads and that seemed to solve the issue.The patient was still completing therapy on the device with no further issues.
 
Event Description
It was reported that the patient was not heating on the arctic sun device.The patient was in cooling mode, but the pads felt warm and water temperature was at 40c.There was also a low flow alert (alert 02).Patient temperature was 33.7c and target was 36c.Ms&s explained that the device was trying to warm the patient up to target, and the pads should not feel cold if the patient was below target.Flow rate was 0.8lpm because the patient only had a universal pad on the their back because they did not have a small set of pads.Ms&s explained that a universal pad alone was not going to do anything.They had a large set of pads and ms&s advised that they could overlap as much as they needed to and use a full set rather than a single universal pad.Per follow up via phone on 30jan2020 the nurse stated they changed the pads and that seemed to solve the issue.The patient was still completing therapy on the device with no further issues.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿incorrect water flow¿.A potential root cause for this failure could be " inadequate channel design".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: "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 maximum number and largest size pads.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 2.3 liters per minute, which is the minimum flow rate for a full pad kit.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.".
 
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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 Key9733418
MDR Text Key183955212
Report Number1018233-2020-01211
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
Type of Report Initial,Followup
Report Date 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number317-00
Was Device Available for Evaluation? No
Date Manufacturer Received03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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