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

Model Number 50000000

Device Problem Overheating of Device (1437)

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

Event Date 12/28/2021

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 hot side connection between the power inlet module and the ac main voltage circuit card showed signs of electrical overstress in the arctic sun device.

Manufacturer Narrative

The reported issue was confirmed.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 o inadequate verification and validation activities of the crimping process o single pull test did not provide stability of process o evidence was not provided when requested for maintenance of records or crimp tools o no crimp cross-sections provided the device was evaluated and the reported issue was confirmed as it was noted that the hot side connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.The power inlet module with main voltage circuit card sn 53049051 was replaced preventatively with a new power inlet module and main voltage circuit card sn 54243645 the l tube from the chiller tank to the main tank and the double bend tube from the main tank had signs of expansion.The device underwent a pm.Circulation pump assembly sn 171206-151 was replaced with assembly sn aa210623-107 and mixing pump assembly sn 171114-066 was replaced with assembly sn aa210623-001.Replaced heater lot 1840 with lot 2145, both manifold o-rings, drain valves.Both the l tube from the chiller tank to the main tank and the double bend tube from the main tank to the manifold due to expansion, and the control panel coin cell due to age.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 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 device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.Labeling review is not required because labeling could not have prevented this issue.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.H3 other text : the actual/suspected device was evaluated.

Event Description

It was reported that the hot side connection between the power inlet module and the ac main voltage circuit card showed signs of electrical overstress in the arctic sun device.

• 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: 13252833
• MDR Text Key: 285046437
• Report Number: 1018233-2021-08799
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• 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: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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