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 09/23/2022

Event Type  malfunction  

Event Description

It was reported that biomed stated the arctic sun device failed calibration for an error 92 (heater test ¿ element 2 failure) and confirmed heating issue by running a functional check.The device had 2395.2 hours and would be coming in for the 2000 hours preventive maintenance.Per sample evaluation results received on (b)(6) 2022, it was reported that the arctic sun device was primed to autofill.It was also noted that the leak was from the chiller pump seal.Per sample evaluation results received on (b)(6) 2022, it was reported that the other repairs completed included replacement of the double bend tube and the chiller evaporator outlet tube due to expansion of the tubes found during servicing.It was noted that the replacement of one tank seal was due to lifting from the tank.Both chiller pump o-rings were replaced, and the pump was reseated to the tank due to leaking found during assessment.It was also noted that a new flowmeter was installed due to inconsistent flow observed during post-repair flow adjustment.It was stated that the upgrades completed included replacing the control panel coin cell due to age.All other applicable upgrades were verified complete in accordance with service procedures.

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 event is not reportable h11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that biomed stated the arctic sun device failed calibration for an error 92 (heater test ¿ element 2 failure) and confirmed heating issue by running a functional check.The device had 2395.2 hours and would be coming in for the 2000 hours preventive maintenance.Per sample evaluation results received on (b)(6) 2022, it was reported that the arctic sun device was primed to autofill.It was also noted that the leak was from the chiller pump seal.Per sample evaluation results received on (b)(6) 2022, it was reported that the other repairs completed included replacement of the double bend tube and the chiller evaporator outlet tube due to expansion of the tubes found during servicing.It was noted that the replacement of one tank seal was due to lifting from the tank.Both chiller pump o-rings were replaced, and the pump was reseated to the tank due to leaking found during assessment.It was also noted that a new flowmeter was installed due to inconsistent flow observed during post-repair flow adjustment.It was stated that the upgrades completed included replacing the control panel coin cell due to age.All other applicable upgrades were verified complete in accordance with service procedures.

• 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: 15519730
• MDR Text Key: 306413470
• Report Number: 1018233-2022-07581
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• 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