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 07/15/2022

Event Type  malfunction  

Event Description

It was reported that the arctic sun device was being preventive maintenance and would not pass the fluid delivery line inlet pressure test.Biomed stated arctic sun device has over 2000 hours and wanted to send in.As per additional information received via follow-up on 07feb2022, it was stated that per wo information there was no patient involvement at the time of reported event.The customer was sending device in for repair and coming in for the 2000 preventive maintenance service.As per sample evaluation, it was reported that the display had stains under the top layer of the screen.The touchscreen sensitivity had failed.The decontamination technician reported that the display was freezing.This was due to the touch screen desensitization.As per sample evaluation results received on 15jul2022, it was stated that the failed valve seals of the fluid delivery line also contributed to the reported issue.It was noted that the replacement of one tank seal was due to lifting during repairs.It was also noted that the double bend tube to the manifold and the evaporator outlet l tube due to expansion discovered during repairs.

Manufacturer Narrative

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

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the arctic sun device was being preventive maintenance and would not pass the fluid delivery line inlet pressure test.Biomed stated arctic sun device has over 2000 hours and wanted to send in.As per additional information received via follow-up on 07feb2022, it was stated that per wo information there was no patient involvement at the time of reported event.The customer was sending device in for repair and coming in for the 2000 preventive maintenance service.As per sample evaluation, it was reported that the display had stains under the top layer of the screen.The touchscreen sensitivity had failed.The decontamination technician reported that the display was freezing.This was due to the touch screen desensitization.As per sample evaluation results received on 15jul2022, it was stated that the failed valve seals of the fluid delivery line also contributed to the reported issue.It was noted that the replacement of one tank seal was due to lifting during repairs.It was also noted that the double bend tube to the manifold and the evaporator outlet l tube due to expansion discovered during repairs.

• 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: 15138285
• MDR Text Key: 302851404
• Report Number: 1018233-2022-05911
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• 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: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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