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

Model Number 50000000

Device Problem Insufficient Cooling (1130)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  malfunction  

Event Description

It was reported that during maintenance the chiller temperature (t4) did not cool down on the arctic sun device.The device was under investigation for the cause and the time was unknown.The device would be evaluated at the imi facility on 25mar2022.Per follow up information received via email on 25mar2022, the device would be evaluated at the imi facility.It was not used on the patient.This issue was confirmed during an operational check by hospital personnel.

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 during maintenance the chiller temperature (t4) did not cool down on the arctic sun device.The device was under investigation for the cause and the time was unknown.The device would be evaluated at the imi facility on 25mar2022.Per follow up information received via email on 25mar2022, the device would be evaluated at the imi facility.It was not used on the patient.This issue was confirmed during an operational check by hospital personnel.Per sample evaluation result received on 15jun2022, the water injection tube was clogged and replaced the water injection tube.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause was not able to be isolated as the reported issue was duplicated during evaluation.The device was evaluated and the reported issue was not able to be confirmed as the issue was not duplicated during testing.No repairs for the reported issue were made.The water injection tube is clogged.Replaced the water injection tube.Device underwent calibration and functional check.Arctic sun passed all tests successfully and unit is ready to be returned to the customer.The device history record review was not required as the reported issue was unconfirmed and not a manufacturing or supplier related failure.Labeling review was not required as the reported event is unconfirmed, 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.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14142977
• MDR Text Key: 289523349
• Report Number: 1018233-2022-02701
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• 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: 09/19/2022

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 Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other