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 07/21/2022

Event Type  malfunction  

Event Description

It was reported that the biomed was performing an inlet pressure test on the fluid delivery line for the 6-month preventive maintenance and noticed the values were out of specifications.The device would be coming in for the 2000 hours preventive maintenance.As per follow up information received on (b)(6) 2022, there was no patient involvement, and coming in for preventive maintenance.As per sample evaluation results received on (b)(6) 2022, the root cause was determined to be a failed circulation pump.The circulation pump motor was replaced due to a cross thread in the motor housing.The tank seals were lifted.The double bend tube was expanded.

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 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.

Manufacturer Narrative

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

Event Description

It was reported that the biomed was performing an inlet pressure test on the fluid delivery line for the 6-month preventive maintenance and noticed the values were out of specifications.The device would be coming in for the 2000 hours preventive maintenance.As per follow-up information received on 04feb2022, there was no patient involvement, and coming in for preventive maintenance.As per sample evaluation results received on 21jul2022, the root cause was determined to be a failed circulation pump.The circulation pump motor was replaced due to a cross thread in the motor housing.The tank seals were lifted.The double bend tube was expanded.

• 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: 15158852
• MDR Text Key: 304610555
• Report Number: 1018233-2022-06019
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• 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: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• 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