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

Model Number 50000000

Device Problem Fracture (1260)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

It was reported that there was physical damage to the shell on the arctic sun device.Users complained that it ¿was not working¿.When mss asked for further clarification, they were unable to provide with any technical details and stated that they would like to send the device in for assessment.As per follow up information received on 17 feb 2022, the device was not being used on a patient during reported event, and it was unknown how the shell was damaged or had any further details on device not working.The device was coming in for repair.As per sample evaluation results received on 26 may 2022, the arctic sun device was primed to fill.A failed mixing pump was causing the device to not cool and a failed circulation pump causing the device to have low flow and autofill failure.The root cause for the device not working was determined to be a failed control panel.The control panel would not boot properly.The root cause for the cracked shell could not be determined.It would take a great force to crack the shell in the area that was damaged.Both manifold o-rings, drain valves, five tank seals found cracked during repairs, the double bend tube to the manifold and the chiller evaporator outlet tube due to deformation.A shock sensor was applied to the lower bracket and loctite to all casters.

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 there is no allegation against the product.

Event Description

It was reported that there was physical damage to the shell on the arctic sun device.Users complained that it ¿was not working¿.When mss asked for further clarification, they were unable to provide with any technical details and stated that they would like to send the device in for assessment.As per follow up information received on 17feb2022, the device was not being used on a patient during reported event, and it was unknown how the shell was damaged or had any further details on device not working.The device was coming in for repair.As per sample evaluation results received on 26-may-2022, the arctic sun device was primed to fill.A failed mixing pump was causing the device to not cool and a failed circulation pump causing the device to have low flow and autofill failure.The root cause for the device not working was determined to be a failed control panel.The control panel would not boot properly.The root cause for the cracked shell could not be determined.It would take a great force to crack the shell in the area that was damaged.Both manifold o-rings, drain valves, five tank seals found cracked during repairs, the double bend tube to the manifold and the chiller evaporator outlet tube due to deformation.A shock sensor was applied to the lower bracket and loctite to all casters.

• 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: 14686545
• MDR Text Key: 300465943
• Report Number: 1018233-2022-04621
• 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: 08/04/2022

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
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/04/2022
• 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