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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2020
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 sun device received a low flow alert (alert 02) and the flow rate was 1.0 lpm.While checking for the kinks in the lines and emptying the arctic gel pads, the nurse stated that there were two arctic gel pads on the thighs.Ms&s explained that this was not sufficient for cooling and not sufficient for maintaining the target temperature.Also, stated that the low flow had nothing to do with the amount of water in the arctic sun device and showed where the water level indicator was located and asked how to fill the arctic sun device.They were targeted for normothermia of 37.0c and the patient temperature was 37.2c, but the nurse stated the temperature had gone up to the 39c range.Ms&s advised that they should get a low reservoir alarm to call back the helpline.The nurse asked whether they could trick the arctic sun device by adding the pads, but not placed them on the patient.Ms&s explained that this could be done, but the arctic sun device would not be efficient in maintaining the target temperature.The patient had some sort of ostomy.
 
Event Description
It was reported that the arctic sun device received a low flow alert (alert 02) and the flow rate was 1.0 lpm.While checking for the kinks in the lines and emptying the arctic gel pads, the nurse stated that there were two arctic gel pads on the thighs.Ms&s explained that this was not sufficient for cooling and not sufficient for maintaining the target temperature.Also, stated that the low flow had nothing to do with the amount of water in the arctic sun device and showed where the water level indicator was located and asked how to fill the arctic sun device.They were targeted for normothermia of 37.0c and the patient temperature was 37.2c, but the nurse stated the temperature had gone up to the 39c range.Ms&s advised that they should get a low reservoir alarm to call back the helpline.The nurse asked whether they could trick the arctic sun device by adding the pads, but not placed them on the patient.Ms&s explained that this could be done, but the arctic sun device would not be efficient in maintaining the target temperature.The patient had some sort of ostomy.
 
Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be, "use of incomplete set".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and lot number for this device was unknown.Therefore, bard was unable to determine the associated labeling to review.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.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTICGEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
MDR Report Key11123333
MDR Text Key225291675
Report Number1018233-2020-22307
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 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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