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

Model Number 50000000

Device Problems Restricted Flow rate (1248); Use of Device Problem (1670)

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

Event Date 02/09/2021

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 the arctic sun device was empty and would not fill at first.Ms&s instructed the nurse to disconnect the pads.Arctic sun device started to fill and then started to leak out from the bottom of machine.Technical support was able to determine if this machine was recently serviced and just sent back.They were guessing that the biomed did not add cleaning solution or fill when they received it.Ms&s instructed nurse to reach out to their biomed to drain machine, add solution and refill.In the meantime, they got the machine working.They were going to finish out therapy and then send device to biomed to be drained, cleaning solution added, and refilled.

Manufacturer Narrative

Per investigator evaluation, bd has determined that this mdr event 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.

Event Description

It was reported that the arctic sun device was empty and would not fill at first.Ms&s instructed the nurse to disconnect the pads.Arctic sun device started to fill and then started to leak out from the bottom of machine.Technical support was able to determine if this machine was recently serviced and just sent back.They were guessing that the biomed did not add cleaning solution or fill when they received it.Ms&s instructed nurse to reach out to their biomed to drain machine, add solution and refill.In the meantime, they got the machine working.They were going to finish out therapy and then send device to biomed to be drained, cleaning solution added, and refilled.

• 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
• MDR Report Key: 11425438
• MDR Text Key: 243963163
• Report Number: 1018233-2021-01034
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• 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?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other