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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTICSUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTICSUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Display or Visual Feedback Problem (1184); Filling Problem (1233)
Patient Problem 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 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.
 
Event Description
It was reported that the arcticsun device displayed an alert 113 (reduced water temperature control).The patient temperature was 34.8c, the target temperature was 35c, the water temperature was 26.7c, and the flow stopped.The inlet pressure was -10.3psi and the circulation pump command was running at 0%.Per troubleshooting, the pads were disconnected and reconnected and therapy restarted.The flow rate remained at 0 l/min and the inlet pressure was -11.8psi.The device was powered off and back on.The device alarmed alarm 05, water reservoir empty.The nurse attempted to fill reservoir, but device did not take the water.It was recommend that the device be sent to biomed.
 
Event Description
It was reported that the arcticsun device displayed an alert 113 (reduced water temperature control).The patient temperature was 34.8c, the target temperature was 35c, the water temperature was 26.7c, and the flow stopped.The inlet pressure was -10.3psi and the circulation pump command was running at 0%.Per troubleshooting, the pads were disconnected and reconnected and therapy restarted.The flow rate remained at 0 l/min and the inlet pressure was -11.8psi.The device was powered off and back on.The device alarmed alarm 05, water reservoir empty.The nurse attempted to fill reservoir, but device did not take the water.It was recommend that the device be sent to biomed.
 
Manufacturer Narrative
Upon further review, bard medical/bd has determined that this mdr was initially reported in error as this event is a duplicate event of another record.
 
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Brand Name
ARCTIC SUN 5000
Type of Device
ARCTICSUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key8448502
MDR Text Key139809262
Report Number1018233-2019-01504
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
Combination Product (y/n)N
PMA/PMN Number
K161602
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 04/04/2019
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 Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/03/2019
Initial Date FDA Received03/25/2019
Supplement Dates Manufacturer Received04/04/2019
Supplement Dates FDA Received04/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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