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

Model Number 50000000E

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

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 had a control panel in the arctic sun device that continued to display the "no" symbol per follow-up information received on 28feb2022, there was no patient involvement, and the device was coming in for repair.Per sample evaluation results received on 03aug2022, it was noted that the double bend tube was deformed.It was also noted that two tank seals were damaged.It was stated that the double bend tube and two tank seals were replaced.Per clarification mail received on 03aug2022, it was confirmed that the seal that seals it in the tank was replaced due to the seal being stretched from the expanded tube that goes through it.The new tube was much smaller in circumference, so that a proper seal between the two could not be obtained in the old, stretched seal.The other seal was replaced when the pumps were removed.The front seal pulled up with the pump.It was also confirmed that another common problem with older seals was removing the pumps at an angle.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as the event was not reportable.H11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that biomed had a control panel in the arctic sun device that continued to display the "no" symbol.Per follow-up information received on 28feb2022, there was no patient involvement, and the device was coming in for repair.Per sample evaluation results received on 03aug2022, it was noted that the double bend tube was deformed.It was also noted that two tank seals were damaged.It was stated that the double bend tube and two tank seals were replaced.Per clarification mail received on 03aug2022, it was confirmed that the seal that seals it in the tank was replaced due to the seal being stretched from the expanded tube that goes through it.The new tube was much smaller in circumference, so that a proper seal between the two could not be obtained in the old, stretched seal.The other seal was replaced when the pumps were removed.The front seal pulled up with the pump.It was also confirmed that another common problem with older seals was removing the pumps at an angle.

• 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: 15227022
• MDR Text Key: 304910229
• Report Number: 1018233-2022-06395
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• 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