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

Model Number 50000000E

Device Problems Restricted Flow rate (1248); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

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.The device was working fine for an hour, then they took off all the pads and sent the patient to cath lab.Upon return they got an alert of low flow.Flow rate was 0.0 l/m and no water seen at connector sites.They disconnected and reconnected using proper technique with no change in flow.Patient temperature was 37.3c and the target temperature was 36.0c.Ms&s advised since it was working before to try changing pads.

Manufacturer Narrative

Bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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.

Event Description

It was reported that there was no flow on the arctic sun device.The device was working fine for an hour, then they took off all the pads and sent the patient to cath lab.Upon return they got an alert of low flow.Flow rate was 0.0 l/m and no water seen at connector sites.They disconnected and reconnected using proper technique with no change in flow.Patient temperature was 37.3c and the target temperature was 36.0c.Ms&s advised since it was working before to try changing pads.

• 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: 10693166
• MDR Text Key: 213504134
• Report Number: 1018233-2020-20211
• 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,literatur
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

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 Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other