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

Model Number 50000000E

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 arcticsun device was not displaying a flow rate.The initial inlet pressure (ip) was -12.5psi.Therapy was stopped to empty the pads, the device displayed an error that said "failure to empty pads completely." another attempt was made and the same failure occurred.The pads were disconnected and the device was placed in manual control.The inlet pressure stayed at -12.5psi.Tech support was contacted, albert advised to unlock the fluid delivery line (fdl) and lock it back into place.Within 3-5 seconds the inlet pressure should zero out.If it does, try restarting therapy.If it does not, then the pressure switch was bad and the device needed to come in for repair (still under warranty).Unlocked/locked fdl and ip stayed at -12.5.Biomed came up to the room and was given albert's number to coordinate a repair.Another device (sn (b)(4)) was available.Started therapy on this device and flow rate settled at 2.5l/min.

Event Description

It was reported that the arcticsun device was not displaying a flow rate.The initial inlet pressure (ip) was -12.5psi.Therapy was stopped to empty the pads, the device displayed an error that said "failure to empty pads completely." another attempt was made and the same failure occurred.The pads were disconnected and the device was placed in manual control.The inlet pressure stayed at -12.5psi.Tech support was contacted, albert advised to unlock the fluid delivery line (fdl) and lock it back into place.Within 3-5 seconds the inlet pressure should zero out.If it does, try restarting therapy.If it does not, then the pressure switch was bad and the device needed to come in for repair (still under warranty).Unlocked/locked fdl and ip stayed at -12.5.Biomed came up to the room and was given albert's number to coordinate a repair.Another device (sn (b)(4) was available.Started therapy on this device and flow rate settled at 2.5l/min.

Manufacturer Narrative

Upon further review, bard medical/bd has determined that this mdr was initially reported in error as this event was a duplicate of another record.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: ARCTICSUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8426141
• MDR Text Key: 139090762
• Report Number: 1018233-2019-01347
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• 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?: Yes
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1