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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS; ARCTIC GEL PADS
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS; ARCTIC GEL PADS Back to Search Results
Catalog Number 317-07
Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
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.The device was not returned.
 
Event Description
It was reported that the device displayed ¿low flow¿.The nurse stated that therapy was temporarily stopped for ct and upon return and reconnection, there was an alert 02 on the device.The flow rate was 1.6 l/min and the inlet pressure was -2.8psi.Per troubleshooting, the pads were disconnected then reconnected and the inlet pressure remained -3psi.Therapy was stopped, the pads were emptied, disconnected, and the device was placed on manual control at 14c.With only the fluid delivery line attached, the system diagnosis showed the flow rate was 1.7 l/min, the inlet pressure was -7psi, and the circulation pump was running at 48%.The pads were connected once more one at a time.The left chest pad showed the flow rate was 0.8 l/min, the inlet pressure was -7psi, and the circulation pump was running at 30%.The right chest pad showed the flow rate was 1.6 l/min, the inlet pressure was -7.3psi, and the circulation pump was running at 43%.The right thigh pad showed that the flow rate was 1.9 l/min, the inlet pressure was -7.1psi, and the circulation pump was running at 53%.The left thigh pad showed that the flow rate was 1.3 l/min, the inlet pressure was -3.3psi, and the circulation pump was running at 100%.The left thigh pad was disconnected and a universal pad was connected.The flow rate was 2.3 l/min, inlet pressure was -7psi, and the circulation pump was running at 58%.It was recommended that the left thigh pad be replaced with a new universal pad.A follow up call was made and the nurse reported that a new universal pad replaced the left thigh pad and the flow rate was 2.8 l/min.Per an additional follow up, therapy continued; however, therapy was stopped later to see if patient is able to sustain temperature on their own.There were no additional issues reported with the device.
 
Event Description
It was reported that the device displayed ¿low flow¿.The nurse stated that therapy was temporarily stopped for ct and upon return and reconnection, there was an alert 02 on the device.The flow rate was 1.6 l/min and the inlet pressure was -2.8psi.Per troubleshooting, the pads were disconnected then reconnected and the inlet pressure remained -3psi.Therapy was stopped, the pads were emptied, disconnected, and the device was placed on manual control at 14c.With only the fluid delivery line attached, the system diagnosis showed the flow rate was 1.7 l/min, the inlet pressure was -7psi, and the circulation pump was running at 48%.The pads were connected once more one at a time.The left chest pad showed the flow rate was 0.8 l/min, the inlet pressure was -7psi, and the circulation pump was running at 30%.The right chest pad showed the flow rate was 1.6 l/min, the inlet pressure was -7.3psi, and the circulation pump was running at 43%.The right thigh pad showed that the flow rate was 1.9 l/min, the inlet pressure was -7.1psi, and the circulation pump was running at 53%.The left thigh pad showed that the flow rate was 1.3 l/min, the inlet pressure was -3.3psi, and the circulation pump was running at 100%.The left thigh pad was disconnected and a universal pad was connected.The flow rate was 2.3 l/min, inlet pressure was -7psi, and the circulation pump was running at 58%.It was recommended that the left thigh pad be replaced with a new universal pad.A follow up call was made and the nurse reported that a new universal pad replaced the left thigh pad and the flow rate was 2.8 l/min.Per an additional follow up, therapy continued; however, therapy was stopped later to see if patient is able to sustain temperature on their own.There were no additional issues reported with the device.
 
Manufacturer Narrative
The reported event was unconfirmed since the sample met specification.The pad was visually inspected and found to have the trim pattern correctly performed, the plastic tubes were found completely assembled covering the total of clamping rings on the plastic connector and the manifold connector, the foams was found free of damages, tears or perforations, the seal between the manifold connector and the pad was found completely sealed, the energy connector was found free of damages, it was noted that there was evidence of the sealing presence on the pad.No manufacturing issues related were noted during the visual evaluation of the pad returned.According the flow rate test method, the flow rate was found to be acceptable on the returned pad.The flow rate for this product must be above 2.4 l/min m2.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: ¿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 fullpad kit.¿.
 
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Brand Name
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
Type of Device
ARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key7395663
MDR Text Key104675264
Report Number1018233-2018-01045
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 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number317-07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2018
Initial Date Manufacturer Received 03/12/2018
Initial Date FDA Received04/04/2018
Supplement Dates Manufacturer Received06/11/2018
Supplement Dates FDA Received06/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient Weight83
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