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

Model Number 50000000E

Device Problem Insufficient Heating (1287)

Patient Problems Death (1802); Respiratory Distress (2045)

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 a patient was insufficiently heating while receiving therapy on an arctic sun device.The patient¿s temperature was 33.8c and the target was 37c.The water temperature was 39.8c and the flow rate was 2.1l/min.The rewarm tab read from 34.8c, at a rate of 0.50c/hour to 37c.Per troubleshooting with ms&s, the nurse added a universal pad and warm blankets.The nurse also turned on the vent warmer and increased the room temperature.A few hours passed and the patient still did not meet the rewarm target.The patient¿s temperature was then 34.4c and the water temperature was 42c.During a follow up call on (b)(6) 2019, the assistant nurse manager, (b)(6), stated the patient was admitted to the icu for respiratory distress and was also receiving continuous renal replacement therapy (crrt).The patient completed therapy on (b)(6) 2019 and was later placed on comfort care measures.Nurse (b)(6) stated the patient expire on (b)(6) 2019 and the cause of death was due to anoxic brain injury related to respiratory distress and was not device related.

Manufacturer Narrative

Per medical affairs review bard/bd has determined that this mdr was initially reported in error as this event is not reportable.

Event Description

It was reported that a patient was insufficiently heating while receiving therapy on an arctic sun device.The patient¿s temperature was 33.8c and the target was 37c.The water temperature was 39.8c and the flow rate was 2.1l/min.The rewarm tab read from 34.8c, at a rate of 0.50c/hour to 37c.Per troubleshooting with ms&s, the nurse added a universal pad and warm blankets.The nurse also turned on the vent warmer and increased the room temperature.A few hours passed and the patient still did not meet the rewarm target.The patient¿s temperature was then 34.4c and the water temperature was 42c.During a follow up call on 04-nov-2019, the assistant nurse manager, (b)(4), stated the patient was admitted to the icu for respiratory distress and was also receiving continuous renal replacement therapy (crrt).The patient completed therapy on (b)(4) 2019 and was later placed on comfort care measures.Nurse (b)(4) stated the patient expire on (b)(4) 2019 and the cause of death was due to anoxic brain injury related to respiratory distress and was not device related.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9290448
• MDR Text Key: 179430476
• Report Number: 1018233-2019-07113
• 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: 12/06/2019

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: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1