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

Catalog Number 50000000E

Device Problem Moisture Damage (1405)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that they spoke to biomed about sending this arctic sun device in for the 2000 hour pm, biomed stated that they would like to send it in because the nurse had issues with the device and condensation on the fluid delivery line (fdl) and warm water delivered for an extended period of time.

Manufacturer Narrative

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

Manufacturer Narrative

The reported issue was unconfirmed.The root cause was not able to be isolated as the reported issue was unconfirmed.The device was evaluated and the reported issue was not duplicated as the device passed testing with no issues.No repairs needed.An electrical safety test was performed.A final inspection was performed.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.The reported event was unconfirmed, therefore dhr review was not required.The reported event was unconfirmed, therefore labeling/packaging review was not required.Correction: d, h 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that they spoke to biomed about sending this arctic sun device in for the 2000 hour pm, biomed stated that they would like to send it in because the nurse had issues with the device and condensation on the fluid delivery line (fdl) and warm water delivered for an extended period of time.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause was not able to be isolated as the reported issue was unconfirmed.The device was evaluated and the reported issue was not duplicated as the device passed testing with no issues.No repairs needed.An electrical safety test was performed.A final inspection was performed.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.The reported issue was unconfirmed and not a manufacturing or supplier related failure, therefore dhr review was not required.The reported event was unconfirmed, labeling/packaging review was not required.Udi related data quality updates only: udi format updated with available product information per gudid as requested.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 they spoke to biomed about sending this arctic sun device in for the 2000 hour pm, biomed stated that they would like to send it in because the nurse had issues with the device and condensation on the fluid delivery line (fdl) and warm water delivered for an extended period of time.

• 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: 17967299
• MDR Text Key: 326072879
• Report Number: 1018233-2023-07595
• Device Sequence Number: 1
• Product Code: DWJ
• 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,Followup
• Report Date: 08/01/2024

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 Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 01/23/2024; 08/01/2024
• Supplement Dates FDA Received: 01/24/2024; 08/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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