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 02/01/2023

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 user replaced the circulation pump, and the arctic sun device was still failing calibration for low flow.It seemed clear that there was a problem with the installation of the pump, but it was difficult to determine root cause over the phone.Mss suggested in bringing the device back for an assessment to determine the cause of the low flow.Per sample evaluation results received on 01feb2023, confirmed flow failure during prewarm flow check during a calibration test unit calibration check.The root cause of the reported issue was due to zero flow through the bypass needle due to the needle being turned all the way clockwise cutting off bypass flow and need adjustment when installed.Properly adjusted manifold bypass flow screw.This needle was never turned out to allow bypass flow.The pinched pressure transducer wire shown in notes was also an indication that the manifold was replaced as the wire was run incorrectly in the frame damaging the wires.There were signs of electrical overstress on the hot side connector between the power inlet module and the main ac voltage circuit card.Double bend tube and chiller evaporator outlet tube were found expanded during servicing.

Event Description

It was reported that the user replaced the circulation pump, and the arctic sun device was still failing calibration for low flow.It seemed clear that there was a problem with the installation of the pump, but it was difficult to determine root cause over the phone.Mss suggested in bringing the device back for an assessment to determine the cause of the low flow.Per sample evaluation results received on 01feb2023, confirmed flow failure during prewarm flow check during a calibration test unit calibration check.The root cause of the reported issue was due to zero flow through the bypass needle due to the needle being turned all the way clockwise cutting off bypass flow and need adjustment when installed.Properly adjusted manifold bypass flow screw.This needle was never turned out to allow bypass flow.The pinched pressure transducer wire shown in notes was also an indication that the manifold was replaced as the wire was run incorrectly in the frame damaging the wires.There were signs of electrical overstress on the hot side connector between the power inlet module and the main ac voltage circuit card.Double bend tube and chiller evaporator outlet tube were found expanded during servicing.

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.A device history record review was not required.Labeling review was 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 inspected.

• 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: 16417794
• MDR Text Key: 310046182
• Report Number: 1018233-2023-01094
• 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: 04/24/2023

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: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• 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