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

Model Number 50000000

Device Problem Nonstandard Device (1420)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

It was reported that the biomed had an arctic sun device that kept failing for an error 3 (pre warm nominal flow error) during calibration.Stated that the system hours were 6991 and was due for the 2k hours preventive maintenance per wo information received on 28 jan 2022, there was no patient involvement.Per sample evaluation results received on (b)(6) 2022, it was reported that there was multiple alarm 2 (low flow) noted throughout the patient data due to low circulation flow with the circulation pump at full power.It was stated that there were signs of electrical overstress at the junction of the power inlet module ac hot side and the connector for the main ac voltage circuit card.It was also stated that during the repairs phase, tank seals were found lifted from the tank.It was also noted that double-bent hose and chiller evaporator hose were found deformed or elongated.

Manufacturer Narrative

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

Event Description

It was reported that the biomed had an arctic sun device that kept failing for an error 3 (pre warm nominal flow error) during calibration.Stated that the system hours were 6991 and was due for the 2k hours preventive maintenance per wo information received on 28jan2022, there was no patient involvement.Per sample evaluation results received on 18jul2022, it was reported that there was multiple alarm 2 (low flow) noted throughout the patient data due to low circulation flow with the circulation pump at full power.It was stated that there were signs of electrical overstress at the junction of the power inlet module ac hot side and the connector for the main ac voltage circuit card.It was also stated that during the repairs phase, tank seals were found lifted from the tank.It was also noted that double-bent hose and chiller evaporator hose were found deformed or elongated.

Manufacturer Narrative

Upon further review, bd has determined that this mdr event is not reportable.

• 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: 15139254
• MDR Text Key: 303177219
• Report Number: 1018233-2022-05931
• 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: 01/25/2023

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: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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