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

Model Number 50000000

Device Problems No Flow (2991); Noise, Audible (3273)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

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 there was no flow on the arctic sun device and the user needed to add water to the arctic sun device but the device would not take up any water.The arctic gel pads were emptied but not disconnected and the water reservoir had 1 bar.The user were getting low water reservoir alert.The disconnected the arctic gel pads but the device would not take up water.Ms&s confirmed placement of the fill tube and had nurse remove the fluid delivery line (fdl).The user could not feel suction but could hear a 'gurgling' sound.The replaced fluid delivery line and the arctic sun device began to fill.

Event Description

It was reported that there was no flow on the arctic sun device and the user needed to add water to the arctic sun device but the device would not take up any water.The arctic gel pads were emptied but not disconnected and the water reservoir had 1 bar.The user were getting low water reservoir alert.The disconnected the arctic gel pads but the device would not take up water.Ms&s confirmed placement of the fill tube and had nurse remove the fluid delivery line (fdl).The user could not feel suction but could hear a 'gurgling' sound.The replaced fluid delivery line and the arctic sun device began to fill.

Manufacturer Narrative

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

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 11258550
• MDR Text Key: 230729947
• Report Number: 1018233-2021-80010
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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: 08/20/2020
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1