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 12/02/2022

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 biomed stated the arctic sun device was not able to generate flow during testing.A functional check showed that the circulation pump could not maintain inlet pressure at -7psi around a pump speed of less than 63 percent.Mss discussed that this was indicative of a failing circulation pump and the option of replacing it locally or sending it in for 2000 hours service package.As per follow up information received on 05may2022, technical support and biomed stated that there was no patient involvement during reported event.Biomed would sending the device for 2000 hours preventive maintenance service.As per sample evaluation result received on 14jun2022, during decontamination the arctic sun device was primed to fill.It was noted that debris was observed passing through shunts during decontamination.It was also noted that the chiller to outer shell mounting bolt broken off inside nut plate.As per sample evaluation results received on 02dec2022, tank seals were replaced due to signs of wear.The evaporator outlet tube and double bend tube to the manifold were replaced due to expansion beyond specification.

Event Description

It was reported that biomed stated the arctic sun device was not able to generate flow during testing.A functional check showed that the circulation pump could not maintain inlet pressure at -7psi around a pump speed of less than 63 percent.Mss discussed that this was indicative of a failing circulation pump and the option of replacing it locally or sending it in for 2000 hours service package.As per follow up information received on 05may2022, technical support and biomed stated that there was no patient involvement during reported event.Biomed would sending the device for 2000 hours preventive maintenance service.As per sample evaluation result received on 14jun2022, during decontamination the arctic sun device was primed to fill.It was noted that debris was observed passing through shunts during decontamination.It was also noted that the chiller to outer shell mounting bolt broken off inside nut plate.As per sample evaluation results received on 02dec2022, tank seals were replaced due to signs of wear.The evaporator outlet tube and double bend tube to the manifold were replaced due to expansion beyond specification.

Manufacturer Narrative

Upon further review, bd has determined that this mdr 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.

• 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: 16013788
• MDR Text Key: 308246730
• Report Number: 1018233-2022-09690
• 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: 03/20/2023

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: 06/08/2022
• 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: 03/21/2023
• Supplement Dates FDA Received: 03/21/2023
• 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