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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; UNKNOWN ARCTIC GEL PAD Back to Search Results
Catalog Number UNKNOWN
Device Problems Inaccurate Flow Rate (1249); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration in Body Temperature (4568)
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 arctic sun device was receiving an alert 01 (patient line open) and no flow when patient was undergoing normo thermia therapy for the last day.The nurse did troubleshooting and changed out the arctic gel pads but the still received a same alerts.Currently, the arctic sun device had no flow even though the therapy initiated.The patient temperature was 40c and the target temperature was 37c.The nurse had place the arctic sun device in manual mode at 5c and ran the device, the outlet monitor temperature (t1) was 16c, the outlet control temperature (t2) was 15.9c, the inlet temperature was 19.7c, the chiller temperature (t4) was 13.4c, the water flow rate was 3 i/m, the inlet pressure was -7.3 psi, the circulation pump command was 74%, the mixing pump command as 100%, the system hours was 6872.1 and the pumping hours was 5815.8.Disabled manual mode and started therapy after about 5 minutes then the water flow rate was 2.8 l/m, the inlet pressure was -7.5 psi and the circulation pump command was 73%.And there were no alerts.Advised to send down to biomed after therapy for pumps to be evaluated based on system and pump hours.
 
Event Description
It was reported that the arctic sun device was receiving an alert 01 (patient line open) and no flow when patient was undergoing normo thermia therapy for the last day.The nurse did troubleshooting and changed out the arctic gel pads but the still received a same alerts.Currently, the arctic sun device had no flow even though the therapy initiated.The patient temperature was 40c and the target temperature was 37c.The nurse had place the arctic sun device in manual mode at 5c and ran the device, the outlet monitor temperature (t1) was 16c, the outlet control temperature (t2) was 15.9c, the inlet temperature was 19.7c, the chiller temperature (t4) was 13.4c, the water flow rate was 3 i/m, the inlet pressure was -7.3 psi, the circulation pump command was 74%, the mixing pump command as 100%, the system hours was 6872.1 and the pumping hours was 5815.8.Disabled manual mode and started therapy after about 5 minutes then the water flow rate was 2.8 l/m, the inlet pressure was -7.5 psi and the circulation pump command was 73%.And there were no alerts.Advised to send down to biomed after therapy for pumps to be evaluated based on system and pump hours.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be, "belt temperatures too low after nip roller and heated section." the lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the arctic gel pads product ifus were found to be adequate based on past reviews.H11:section a through f - 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.H3 other text : the device was not returned.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTIC GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key10553061
MDR Text Key208741405
Report Number1018233-2020-06029
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 01/08/2021
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 Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/28/2020
Initial Date FDA Received09/18/2020
Supplement Dates Manufacturer Received12/20/2020
Supplement Dates FDA Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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