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

Model Number 50000000E

Device Problem Nonstandard Device (1420)

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

Event Date 07/25/2022

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 biomed stated that the arctic sun device was getting low flow alerts and the inlet pressure was 0.0psi.The device had a bad circulation pump, and the system hours were 9416.Per sample evaluation results received on (b)(6) 2022, it was noted that the hot side connection between the power inlet module and the main voltage circuit card and the chiller power connector to the main voltage circuit card show signs of electrical overstress.It was stated that windows errors detected on the control panel screen during therapy mode causing the screen to freeze.The speaker volume was barely audible on the highest volume setting.The molded y tube from the chiller pump to the evaporator tank had cuts found in it.The tank seals were lifting from the tank.The double-bend tube had deformation and expansion.A pinhole in the control panel clear screen cover was noted with stains found under the clear plastic screen cover.It was also stated that it did not appear to affect touchscreen functionality.It was also noted the arctic sun device would not autofill.

Event Description

It was reported that biomed stated that the arctic sun device was getting low flow alerts and the inlet pressure was 0.0psi.The device had a bad circulation pump, and the system hours were 9416.Per sample evaluation results received on 25jul2022, it was noted that the hot side connection between the power inlet module and the main voltage circuit card and the chiller power connector to the main voltage circuit card show signs of electrical overstress.It was stated that windows errors detected on the control panel screen during therapy mode causing the screen to freeze.The speaker volume was barely audible on the highest volume setting.The molded y tube from the chiller pump to the evaporator tank had cuts found in it.The tank seals were lifting from the tank the double-bend tube had deformation and expansion.A pinhole in the control panel clear screen cover was noted with stains found under the clear plastic screen cover.It was also stated that it did not appear to affect touchscreen functionality.It was also noted the arctic sun device would not autofill.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error.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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15190803
• MDR Text Key: 305255674
• Report Number: 1018233-2022-06176
• 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: 02/07/2023

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 Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/08/2023
• 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