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 12/05/2022

Event Type  malfunction  

Event Description

It was reported that the biomed had a arctic sun device that was due for the 2000 hour preventive maintenance service and seemed to be having issues filling so wanted the 2000 hour preventive maintenance done and the level sensor checked.Per additional information received via customer service on 02nov2022, it was reported that the estimate has been approved and was in transit to come in for 2000 hour preventive maintenance and repair.Per sample evaluation result received on 02dec2022, it was reported that the circulation pump motor had broken standoffs and requires replacement.The mixing pump motor was making a grinding noise and requires replacement.All tank tubing was expanded.

Manufacturer Narrative

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

Manufacturer Narrative

Upon per review, bd has determined that this mdr event is 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.

Event Description

It was reported that the biomed had a arctic sun device that was due for the 2000 hour preventive maintenance service and seemed to be having issues filling so wanted the 2000 hour preventive maintenance done and the level sensor checked.As per additional information received via customer service on 02nov2022, it was reported that the estimate has been approved and was in transit to come in for 2000 hour preventive maintenance and repair.As per sample evaluation result received on 02dec2022, it was reported that the circulation pump motor had broken standoffs and requires replacement.The mixing pump motor was making a grinding noise and requires replacement.All tank tubing 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: 16014258
• MDR Text Key: 306366056
• Report Number: 1018233-2022-09698
• 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: 03/28/2023

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: 11/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 03/29/2023
• 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