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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS UNKNOWN ARCTIC GEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS UNKNOWN ARCTIC GEL PADS Back to Search Results
Catalog Number UNKNOWN
Device Problems Insufficient Flow or Under Infusion (2182); Device Sensing Problem (2917)
Patient Problem Alteration In Body Temperature (2682)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the normothermia patient was on arctic sun device. They were getting a low flow alert (alert 02). The pads may be on due to be changed. The nurse attempted to empty the pads, but received alert 07 (empty pads cycle not complete). Disconnected pads and placed device in manual mode. Fluid delivery line showed flow rate of 1. 7lpm, inlet pressure of 7. 0psi, circulation pump command 45%. Left chest flow rate was 1. 6lpm, inlet pressure was 7. 1psi, circulation pump command 45%. Right chest flow rate of 1. 7lpm, inlet pressure -7. 1psi, circulation pump command 45%. Left thigh flow rate of 2. 2lpm, inlet pressure -7. 3psi, circulation pump command 52%. Right thigh: flow rate 2. 1lpm, inlet pressure -7. 0psi, circulation pump command 59%. System hours 3794. Pump hours 3301. Placed device back on automatic mode. Flow 2. 1lpm. While testing the flow of the device it gave a low patient temperature alert. Patient temperature read 15. 3c. The foley probe was on use. Nurse adjusted the probe and now temperature reads 36. 2c. Explained that the probe or temperature in cable needs to be changed should the patient's temperature drop like that again. Nurse stated that the device accidentally came unplugged from the wall earlier and thought that was when the alerts began.
 
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Brand NameARCTIC GEL PADS
Type of DeviceUNKNOWN ARCTIC GEL PADS
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 Key10465121
MDR Text Key227880403
Report Number1018233-2020-05501
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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