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

Model Number 50000000L

Device Problem Nonstandard Device (1420)

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

Event Date 12/08/2022

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 booting up and the device control panel did not boot up.A test control panel was installed, and unit powered up and control panel functioned nominally and user interface to complete decontamination.It was also observed that the test mixing pump was installed in decontamination for unit to cool which would be addressed in preventive maintenance.Per sample evaluation, it was reported that the tank tubing was expanded.

Manufacturer Narrative

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

Event Description

It was reported that the arctic sun device was not booting up and the device control panel did not boot up.A test control panel was installed, and unit powered up and control panel functioned nominally and user interface to complete decontamination.It was also observed that the test mixing pump was installed in decontamination for unit to cool which would be addressed in preventive maintenance.Per sample evaluation, it was reported that the tank tubing was expanded.Per sample evaluation results received on 29mar2023, it was reported that the tank tubing such as double bend tube and l shape formed tube were found be expanded.It was stated that the double bend tube and l shape formed tube were replaced.

• 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: 16051887
• MDR Text Key: 308370204
• Report Number: 1018233-2022-09836
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159
• 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: 04/12/2023

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: 50000000L
• Device Catalogue Number: 50000000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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