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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 Defective Component (2292); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2023
Event Type  malfunction  
Event Description
It was reported that the arctic sun device was sent down from the emergency department (ed) for having an air leak and not cooling.The dean stated that the department lost the fluid delivery line (fdl) after someone tore it.Per follow up information received on (b)(6)2022, the biomed states there was no patient injury and has no further information regarding patient.Biomed ran a calibration on device and passed all the tests did not confirm reported issue.After sending the data files to tech support, it was confirmed device was in need for the 2k pm service they would be sending device in for service.Per sample evaluation results received on (b)(6)2023, the root cause was isolated to a faulty circulation pump.It was reported that the device was unable to cool during therapy and that the fluid delivery line was noted to have a tear in it.It was noted that the torn fluid delivery line was not returned for evaluation.It was stated that the double bend tube, the chiller evaporator outlet tube were expanded.The tank seals were lifted and torn.The mixing pump head motor bearing was seizing.The chiller pump outlet molded tub had a kink causing restricting flow through the cooling system.The flow meter displayed inaccurate readings from a sticking impeller.It was also noted that the double bend tube, chiller evaporator outlet tube and tank seals were replaced.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Manufacturer Narrative
The reported issue was confirmed.The root cause was isolated to a faulty flow meter.The device was evaluated and the reported issue was confirmed as it was noted that the flow meter displayed inaccurate readings from a sticking impeller.The flow meter was replaced.Dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Therefore, labeling review was not required.H11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.
 
Event Description
It was reported that the arctic sun device was sent down from the emergency department (ed) for having an air leak and not cooling.The dean stated that the department lost the fluid delivery line (fdl) after someone tore it.Per follow up information received on 15-aug-2022, the biomed states there was no patient injury and has no further information regarding patient.Biomed ran a calibration on device and passed all the tests did not confirm reported issue.After sending the data files to tech support, it was confirmed device was in need for the 2k pm service they would be sending device in for service.Per sample evaluation results received on 07-feb-2023, the root cause was isolated to a faulty circulation pump.It was reported that the device was unable to cool during therapy and that the fluid delivery line was noted to have a tear in it.It was noted that the torn fluid delivery line was not returned for evaluation.It was stated that the double bend tube, the chiller evaporator outlet tube were expanded.The tank seals were lifted and torn.The mixing pump head motor bearing was seizing.The chiller pump outlet molded tub had a kink causing restricting flow through the cooling system.The flow meter displayed inaccurate readings from a sticking impeller.It was also noted that the double bend tube, chiller evaporator outlet tube and tank seals were replaced.
 
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Brand Name
ARCTIC SUN® 5000
Type of Device
ARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key16452074
MDR Text Key310337455
Report Number1018233-2023-01278
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 Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/03/2023
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 Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2023
Initial Date FDA Received02/28/2023
Supplement Dates Manufacturer Received05/03/2023
Supplement Dates FDA Received05/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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