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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARCTICSUN GEL PADS
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARCTICSUN GEL PADS Back to Search Results
Device Problems Inaccurate Flow Rate (1249); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
 
Event Description
It was reported that the patient was above target temperature while in normothermia mode.The nurse stated that the patient was shivering and the water temperature was between 5c and 10c.The patient temperature was 37.6c, and the target temperature was 37c.The flow rate was fluctuating between moderate and good.The nurse wanted to know if it made sense to continue normothermia mode since the patient required shivering management.Per troubleshooting, the nurse was advised to troubleshoot for the marginal flow rate, and the patient shivering was likely due to the cold water temperature.The flow rate was greater than 2.0 l/min.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use was found adequate and states 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 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.".
 
Event Description
It was reported that the patient was above target temperature while in normothermia mode.The nurse stated that the patient was shivering and the water temperature was between 5c and 10c.The patient temperature was 37.6c, and the target temperature was 37c.The flow rate was fluctuating between moderate and good.The nurse wanted to know if it made sense to continue normothermia mode since the patient required shivering management.Per troubleshooting, the nurse was advised to troubleshoot for the marginal flow rate, and the patient shivering was likely due to the cold water temperature.The flow rate was greater than 2.0 l/min.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
ARCTICSUN GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key7931125
MDR Text Key122642296
Report Number1018233-2018-04599
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
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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