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 01/31/2023

Event Type  malfunction  

Event Description

It was reported that the arctic sun device booted to an alarm 74 (non-recoverable system error).Biomed explained this was indicative of a t2 (outlet control temperature) thermistor failure.Per follow up information received via email on (b)(6) 2022, there was no patient involvement.Per sample evaluation results received on (b)(6) 2023, the root cause was isolated to a faulty t2 (outlet control temperature) thermistor on the tank harness.It was reported the hot side connection between the power inlet module and the ac main voltage circuit card showed signs of electrical overstress.

Manufacturer Narrative

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

Manufacturer Narrative

The reported issue was confirmed.The device was evaluated and the reported issue was confirmed as it was noted the hot side connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.Preventatively replaced ac main voltage circuit card.Completed the 2000-hour pm procedure on the device.Serviced the circulation pump and mixing pump, replaced the heater lot 1902 with lot 2205, and replaced both manifold o-rings and drain valves the device was put through a functional check.The device was heated to 42°c and cooled to 4°c and was stable at 28°c with a flow of 1.8 l/m with -7.0 psi in bypass mode.The device was placed on acats (automated calibration and test system).An electrical safety test was performed.A 45 hour burn in was performed.A final inspection was performed.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.The overheating of the wires was assessed by the investigation tasks and used to complete the root cause evaluation using the fishbone methodology (refer to ac cca power inlet module powerpoint for fishbone diagram).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.The dhr review is not required and the 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.

Event Description

It was reported that the arctic sun device booted to an alarm 74 (non-recoverable system error).Biomed explained this was indicative of a t2 (outlet control temperature) thermistor failure.Per follow up information received via email on 02-aug-2022, there was no patient involvement.Per sample evaluation results received on 31-jan-2023, the root cause was isolated to a faulty t2 (outlet control temperature) thermistor on the tank harness.It was reported the hot side connection between the power inlet module and the ac main voltage circuit card showed signs of electrical overstress.

• 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: 16410508
• MDR Text Key: 310134510
• Report Number: 1018233-2023-01048
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• 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: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• 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