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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 50000000E
Device Problems Break (1069); Restricted Flow rate (1248); Device Displays Incorrect Message (2591)
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 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 flow rate was 0 l/min and the device stopped once the pads were reconnected, when the patient returned from ct. The device read alert 01 (patient line opened). There was four pads in place with good coverage, the target temperature was 37c and the patients temperature 37c. With the pads attached the flow rate was 0 l/min, the inlet pressure was -0. 4 psi, and the circulation pump command was running at 100%. The pads and fluid delivery line were examined for damages and none were noted. The pads were disconnected and reconnected, holding only the blue foam tubing. Therapy was restarted and the flow rate was still sub-optimal at 1 l/min and then dropped to 0 l/min. The fluid delivery line (fdl) was disconnected and the nurse stated there was strong suction. The fdl was attached and the flow remained at 0 l/min. The pads were disconnected and the nurse noted that the left chest pad appeared to be broken with a ragged edge on the clear connectors. The nurse stated that the patient required therapy for a longer period of time and would just exchange all the pads. Ms&s called nurse back an hour later and it was noted that only two pads were exchanged and the flow was still 0 l/min. It was recommended that the other two pads be exchanged. Ms&s followed up again and the nurse connected a new set of pads and the flow rate was still 0 l/min. It was recommended the device was exchanged. Per additional information received, the patient was in normothermia therapy and the patient was maintaining target temperature.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTICSUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7639707
MDR Text Key112720096
Report Number1018233-2018-02434
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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