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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; UNKNOWN ARCTIC GEL PADS
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; UNKNOWN ARCTIC GEL PADS Back to Search Results
Device Problems Insufficient Flow or Under Infusion (2182); Misassembly by Users (3133)
Patient Problems Shaking/Tremors (2515); Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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 sun device was getting low flow and getting an alarm that the water temperature too low for too long.Therapy had been started at 05:30, the patient temperature was 34.6c, the target temperature was 33c, the water temperature was 5c, the flow rate was 1.5 l/m.The patient was about 400 lbs.Patient was shivering and having myoclonic jerks.There were 5 arctic gel pads in use and trend with one arrow down.The temperature was reading via esophageal and foley probe and correlating.The patient was on propofol and was getting tylenol and buspar.Disconnected and reconnected arctic gel pads were using proper technique.The flow rate was 1.8-2.1 l/m.Recommended checking skin under arctic gel pads to assess for skin injury and ensuring that the arctic gel pads were not bunching up under the patient.Advised that myoclonic jerks and shivering was a cause of patient not achieving target temperature.
 
Manufacturer Narrative
The reported event was confirmed as user related issue.Potential root cause for this failure could be "misconnection of supply and return lines".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the arctic gel pad product ifus were found to be adequate based on past reviews.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 device was not returned.
 
Event Description
It was reported that the arctic sun device was getting low flow and getting an alarm that the water temperature too low for too long.Therapy had been started at 05:30, the patient temperature was 34.6c, the target temperature was 33c, the water temperature was 5c, the flow rate was 1.5 l/m.The patient was about 400 lbs.Patient was shivering and having myoclonic jerks.There were 5 arctic gel pads in use and trend with one arrow down.The temperature was reading via esophageal and foley probe and correlating.The patient was on propofol and was getting tylenol and buspar.Disconnected and reconnected arctic gel pads were using proper technique.The flow rate was 1.8-2.1 l/m.Recommended checking skin under arctic gel pads to assess for skin injury and ensuring that the arctic gel pads were not bunching up under the patient.Advised that myoclonic jerks and shivering was a cause of patient not achieving target temperature.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key10607045
MDR Text Key209187915
Report Number1018233-2020-06256
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 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/09/2020
Initial Date FDA Received09/30/2020
Supplement Dates Manufacturer Received11/04/2020
Supplement Dates FDA Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight181
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