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

Model Number 50000000

Device Problems Computer Software Problem (1112); Defective Component (2292)

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

Event Date 03/15/2022

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 would not fill.A functional check showed that the circulation pump would not generate pressure.They would like to send the device in for a 2k hour service.Per follow up via phone 30jun2021, biomed did not know whether the issue was found during therapy or during maintenance.Per sample evaluation, it was reported that the circulation pump motor was locked and the axel would not turn.When attempting to upgrade the software from version 2.0.1 to version 3.0.2 at end of service, device received an error and could not save parameters to the hard drive.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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 actual/suspected device was inspected.

Event Description

It was reported that the arctic sun device would not fill.A functional check showed that the circulation pump would not generate pressure.They would like to send the device in for a 2k hour service.Per follow up via phone 30jun2021, biomed did not know whether the issue was found during therapy or during maintenance.Per sample evaluation, it was reported that the circulation pump motor was locked and the axel would not turn.When attempting to upgrade the software from version 2.0.1 to version 3.0.2 at end of service, device received an error and could not save parameters to the hard drive.Circulation pump motor was replaced.Control panel was replaced.Mixing pump was serviced.Heater was replaced.Drain valves were replaced.Per sample evaluation results received on 30aug2022, it was reported that installed test mixing pump to cool.

• 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: 14077634
• MDR Text Key: 289083326
• Report Number: 1018233-2022-02237
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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