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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS; ARCTICSUN GEL PADS
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MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS; ARCTICSUN GEL PADS Back to Search Results
Device Problems Use of Device Problem (1670); Temperature Problem (3022)
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.Device evaluated by mfr: the device was not returned.
 
Event Description
It was reported that the flow rate was suboptimal at 1.3 l/min.The patients temperature dropped below the 33c target to 32.5c.There were 4 pads in place with good coverage, a bladder probe (bard temp sensing foley) connected to the arcticsun device and rectal probe in temp port 2.There was minimal urine output.Temperatures were correlating.The complainant confirmed that the bard temp sensing foley catheters were accurate with minimal urine output.Mss walked the nurse through disconnecting and reconnecting the pads, avoiding the clear connectors.The nurse stated that the flow rate was up to 1.5 l/min.Reasons why a patient's temperature might drop below target were discussed.It was recommended that she cover the patient's hands, head and feet and add a blanket for additional warmth.Overshoot was discussed.Per call back one hour later, the flow rate was 1.7-1.8l/min and the patient's temperature was 33.2c.No blankets had been added.
 
Manufacturer Narrative
Upon further review, bard medical/bd has determined that this mdr was initially reported in error as this event is not reportable.
 
Event Description
It was reported that the flow rate was suboptimal at 1.3 l/min.The patients temperature dropped below the 33c target to 32.5c.There were 4 pads in place with good coverage, a bladder probe (bard temp sensing foley) connected to the arcticsun device and rectal probe in temp port 2.There was minimal urine output.Temperatures were correlating.The complainant confirmed that the bard temp sensing foley catheters were accurate with minimal urine output.Mss walked the nurse through disconnecting and reconnecting the pads, avoiding the clear connectors.The nurse stated that the flow rate was up to 1.5 l/min.Reasons why a patient's temperature might drop below target were discussed.It was recommended that she cover the patient's hands, head and feet and add a blanket for additional warmth.Overshoot was discussed.Per call back one hour later, the flow rate was 1.7-1.8l/min and the patient's temperature was 33.2c.No blankets had been added.
 
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Brand Name
ARTICGEL PADS
Type of Device
ARCTICSUN GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key8500933
MDR Text Key142415456
Report Number1018233-2019-01819
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 04/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received04/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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