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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Air Leak (1008); Leak/Splash (1354); Infusion or Flow Problem (2964)
Patient Problems Death (1802); Hyperthermia (1909); Sepsis (2067); No Consequences Or Impact To Patient (2199)
Event Date 04/29/2018
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 while a patient who was admitted for sepsis and malignant hyperthermia was rewarming on the arctic sun device, s/n (b)(4), the screen message was reading low air leak. The flow rate would increase for approximately two minutes after the machine was started, then the flow rate would drop again. There were four pads in use and the patient had recently returned from a ct scan. The facility called the ms&s helpline on (b)(6) 2018 at 10:07pm. The therapy was stopped at the time of the call. The helpline had the nurse restart the device. The flow rate was 0lpm, inlet pressure was 0. 9psi, circulation pump was at 100%, cv was 0, system hours were 3079, and pump hours were 2759. The nurse received alert 01 (patient line open). The helpline gave the option of changing the device out or troubleshooting the pads. The nurse opted to change the device first. The md ordered that the device be discontinued and the patient was placed on a bair hugger for comfort measures. The helpline called the facility back at 03:30am on (b)(6) 2018 and was informed that therapy had been discontinued due to the patient being placed on comfort care. Per the ccu night nurse supervisor, (b)(6), the patient expired on (b)(6) 2018 due to sepsis and malignant hyperthermia not related to the arctic sun device. The patient had a history of drug abuse. The device was sent to biomed for troubleshooting.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN 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
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7539080
MDR Text Key109252368
Report Number1018233-2018-01837
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
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 Received05/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2012
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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