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

Model Number 50000000E

Device Problem Nonstandard Device (1420)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

It was reported that the biomed was not near the arctic sun device, but stated it was foaming.Also stated that they would like to send the device in for 2000-hour service.Per follow up information received via email on 14-feb-2022, biomed was not around the device during the reported issue and would be sending in for repair and it was unknown the device was being used during reported event.Per sample evaluation results received on 15-aug-2022, the root cause was determined to be cavitation from a weak circulation pump causing micro bubbles to appear.The reported issue was confirmed and what appeared to be foaming in the water that turned out to be micro air bubbles passing through the test loops attached to the end of the fluid delivery line at startup of the circulation pump.After a few minutes the bubbles cleared.Windows error on control panel.Voice and chime through control panel speaker very faint at maximum speaker setting of 5.Double bend tube was noted to be expanded.

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 biomed was not near the arctic sun device, but stated it was foaming.Also stated that they would like to send the device in for 2000-hour service.Per follow up information received via email on 14-feb-2022, biomed was not around the device during the reported issue and would be sending in for repair and it was unknown the device was being used during reported event.Per sample evaluation results received on (b)(6) 2022, the root cause was determined to be cavitation from a weak circulation pump causing micro bubbles to appear.The reported issue was confirmed and what appeared to be foaming in the water that turned out to be micro air bubbles passing through the test loops attached to the end of the fluid delivery line at startup of the circulation pump.After a few minutes the bubbles cleared.Windows error on control panel.Voice and chime through control panel speaker very faint at maximum speaker setting of 5.Double bend tube was noted to be expanded.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as the event was not reportable.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.

• 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: 15266066
• MDR Text Key: 305252633
• Report Number: 1018233-2022-06609
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• 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