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

Model Number 50000000E

Device Problem Overheating of Device (1437)

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

Event Date 02/22/2023

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 was not cooling.A check of the diagnostics showed chiller temperature (t4) at 29 degrees.They had biomed to drain the chiller tank and nurse stated that it drained over 600 ml biomed stated that this was indicative of a failed chiller.Per follow up information received via email on 25jan2023, there was no patient involvement.The device was coming in for service.Per sample evaluation result received on (b)(6) 2022, the root cause of the reported issue was due to a failed chiller unit.It was reported that the neutral side connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.It was stated that sheared bolt head on outer shell to chiller frame.It was also stated that double bend tube found expanded.It was noted that one tank seal found lifted.It was also noted that replaced the ac main voltage circuit card, double bend tube and one tank seal.

Manufacturer Narrative

The reported issue was confirmed.It was concluded that the following was the root cause: supplier ¿ root cause: inadequate verification and validation activities of the crimping process; single pull test did not provide stability of process; evidence was not provided when requested for maintenance of records or crimp tools; no crimp cross-sections provided.It was known that the device did not meet specifications and that the device was influenced by the reported failure.The device was not in use on a patient.A device history record review was not required.Labeling review is not required because labeling could not have prevented this issue.H11: section a through f - the information provided by bd represents all 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 was not cooling.A check of the diagnostics showed chiller temperature (t4) at 29 degrees.They had biomed to drain the chiller tank and nurse stated that it drained over 600 ml biomed stated that this was indicative of a failed chiller.As per follow up information received via email on 25jan2023, there was no patient involvement.The device was coming in for service.As per sample evaluation result received on 22feb2022, the root cause of the reported issue was due to a failed chiller unit.It was reported that the neutral side connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.It was stated that sheared bolt head on outer shell to chiller frame.It was also stated that double bend tube found expanded.It was noted that one tank seal found lifted.It was also noted that replaced the ac main voltage circuit card, double bend tube and one tank seal.

• 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: 16543989
• MDR Text Key: 311297449
• Report Number: 1018233-2023-01734
• 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: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2018
• 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