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

Model Number 50000000E

Device Problem Fracture (1260)

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

Event Date 04/15/2022

Event Type  malfunction  

Event Description

It was reported that the arctic sun device received an error 80 (non-recoverable system error) during calibration.Per follow up via phone 03aug2021, initial reporter, biomed stated that no patient involvement and during preventative maintenance the arctic sun would not cool.After spoke with tech support, it was determined that arctic sun device had a failed mixing pump and circulation pump and would need to be sent to the depot for repair.As per additional information received via ucc on 24sep2021, there was no circulation pump issue was found and just a bad mixing pump.Because of the hours and the mixing pump failure, recommended that the user sent it in for the 2k preventive maintenance service and got the rest of the components replaced at the same time.It appeared that the depot did not had any issues with it either since they only had to put a mixing test pump in it to run the disinfection.Per sample evaluation, it was reported that the isolation board, patient temperature connector, terminal soldered pins were cracked at the circuit board, but unit was operational.It stated that the grounding label was missing for power cord.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.

Event Description

It was reported that the arctic sun device received an error 80 (non-recoverable system error) during calibration.Per follow up via phone 03aug2021, initial reporter, biomed stated that no patient involvement and during preventative maintenance the arctic sun would not cool.After spoke with tech support, it was determined that arctic sun device had a failed mixing pump and circulation pump and would need to be sent to the depot for repair.As per additional information received via ucc on 24sep2021, there was no circulation pump issue was found and just a bad mixing pump.Because of the hours and the mixing pump failure, recommended that the user sent it in for the 2k preventive maintenance service and got the rest of the components replaced at the same time.It appeared that the depot did not had any issues with it either since they only had to put a mixing test pump in it to run the disinfection.Per sample evaluation, it was reported that the isolation board, patient temperature connector, terminal soldered pins were cracked at the circuit board, but unit was operational.It stated that the grounding label was missing for power cord.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14361369
• MDR Text Key: 291497284
• Report Number: 1018233-2022-03614
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 06/06/2022

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: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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