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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS; ARCTIC SUN GEL PADS
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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS; ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 318-02-02
Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)
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.The device was not returned.
 
Event Description
It was reported that the arctic sun device had received an alert 113 and the flow rate was 0.9 lpm, but had gotten as low as 0.5 lpm.The inlet pressure was -7 psi.System hours were 354 and pump hours were 310.The pads were disconnected and reconnected and the flow rate rose to 1.1 lpm.The patient's temperature was 33.8c with a target temperature of 33.5c.The water temperature was 29.3c.The tubing was confirmed to be straight and unobstructed.The reservoir showed 5 bars.The biomed was instructed to stop therapy, disconnect the pad, and drain 500ml of water from the device.In manual control, the device was able to heat and cool appropriately.With the pad reconnected and therapy restarted, the patient's temperature was 33.4c and the flow rate was 1lpm.The trend device indicator showed two arrows down.Additional information was received from the facility on 12jun2019, that the patient completed therapy successfully.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿poor flow¿ with a potential root cause of ¿improper storage causing crushed pad, pad dimples, and/or pad line¿.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: "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.".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 had received an alert 113 and the flow rate was 0.9 lpm, but had gotten as low as 0.5 lpm.The inlet pressure was -7 psi.System hours were 354 and pump hours were 310.The pads were disconnected and reconnected and the flow rate rose to 1.1 lpm.The patient's temperature was 33.8c with a target temperature of 33.5c.The water temperature was 29.3c.The tubing was confirmed to be straight and unobstructed.The reservoir showed 5 bars.The biomed was instructed to stop therapy, disconnect the pad, and drain 500ml of water from the device.In manual control, the device was able to heat and cool appropriately.With the pad reconnected and therapy restarted, the patient's temperature was 33.4c and the flow rate was 1lpm.The trend device indicator showed two arrows down.Additional information was received from the facility on 12jun2019, that the patient completed therapy successfully.
 
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Brand Name
ARCTICGEL PADS
Type of Device
ARCTIC SUN GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key8748458
MDR Text Key149800458
Report Number1018233-2019-03475
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 07/23/2019
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 Number318-02-02
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/11/2019
Initial Date FDA Received07/01/2019
Supplement Dates Manufacturer Received07/02/2019
Supplement Dates FDA Received07/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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