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

Model Number 50000000

Device Problems Display or Visual Feedback Problem (1184); Filling Problem (1233)

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.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 the arcticsun device displayed an alert 113 (reduced water temperature control).The patient temperature was 34.8c, the target temperature was 35c, the water temperature was 26.7c, and the flow stopped.The inlet pressure was -10.3psi and the circulation pump command was running at 0%.Per troubleshooting, the pads were disconnected and reconnected and therapy restarted.The flow rate remained at 0 l/min and the inlet pressure was -11.8psi.The device was powered off and back on.The device alarmed alarm 05, water reservoir empty.The nurse attempted to fill reservoir, but device did not take the water.It was recommend that the device be sent to biomed.

Event Description

It was reported that the arcticsun device displayed an alert 113 (reduced water temperature control).The patient temperature was 34.8c, the target temperature was 35c, the water temperature was 26.7c, and the flow stopped.The inlet pressure was -10.3psi and the circulation pump command was running at 0%.Per troubleshooting, the pads were disconnected and reconnected and therapy restarted.The flow rate remained at 0 l/min and the inlet pressure was -11.8psi.The device was powered off and back on.The device alarmed alarm 05, water reservoir empty.The nurse attempted to fill reservoir, but device did not take the water.It was recommend that the device be sent to biomed.

Manufacturer Narrative

Upon further review, bard medical/bd has determined that this mdr was initially reported in error as this event is a duplicate event of another record.

• 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: 8448502
• MDR Text Key: 139809262
• Report Number: 1018233-2019-01504
• 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: 04/04/2019

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: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/03/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1