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

Model Number 50000000E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hypothermia (1915); Alteration In Body Temperature (2682)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported on (b)(6) 2020 that an arctic sun device alarmed patient temperature below target and stopped.The neonate¿s temperature was 29.7c and the target temperature was 33.5c.The patient was admitted to the nicu and placed on therapy for hypothermia.Ms&s was called for assistance.The nurse stated the doctor ordered a bair hugger to be placed and then restart therapy when the patient was closer to 33c.Ms&s offered to review the event log on the device to troubleshoot the issue and possibly get therapy going again.The nurse said she was going to follow the physician¿s orders and would call back if she had any issues.Ms&s followed up via phone to attempt troubleshooting on (b)(6) 2020.The nurse commented that a new nurse was taking over patient care and would call if there were any issues.During a follow-up phone call made by the fa specialist on 12-feb-2020 to the facility, the nicu nurse stated the device was working fine and the device was no longer in use because the patient had expired.A clinical follow was completed on (b)(6) 2020 via phone and charge the nurse confirmed that the patient was hypothermic.He stated they were able to restart therapy; however, the patient did not complete therapy due to the patient expiring.Charge nurse phillip could not confirm the cause of death.

Manufacturer Narrative

Upon review of additional information, bard/bd has determined that this event is not reportable.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.The device was not returned.

Event Description

It was reported on (b)(6) 2020 that an arctic sun device alarmed patient temperature below target and stopped.The neonate¿s temperature was 29.7c and the target temperature was 33.5c.The patient was admitted to the nicu and placed on therapy for hypothermia.Ms&s was called for assistance.The nurse stated the doctor ordered a bair hugger to be placed and then restart therapy when the patient was closer to 33c.Ms&s offered to review the event log on the device to troubleshoot the issue and possibly get therapy going again.The nurse said she was going to follow the physician¿s orders and would call back if she had any issues.Ms&s followed up via phone to attempt troubleshooting on (b)(6) 2020.The nurse commented that a new nurse was taking over patient care and would call if there were any issues.During a follow-up phone call made by the fa specialist on (b)(6) 2020 to the facility, the nicu nurse stated the device was working fine and the device was no longer in use because the patient had expired.A clinical follow up was completed on (b)(6) 2020 via phone and charge the nurse confirmed that the patient was hypothermic.He stated they were able to restart therapy; however, the patient did not complete therapy due to the patient expiring.Charge nurse (b)(6) could not confirm the cause of death.Per additional information received via email from the bd clinical manager on 05-march-2020, the neonate was a homebirth and was unresponsive after delivery.The midwife tried to resuscitate the baby for about an hour and there was a delay in transport to the emergency room.The neonate expired on (b)(6) 2020.The clinical manager also provided case data.Per evaluation of the case data by a bd quality engineer, the patient was being maintained at 33.5c.The patient¿s temperature was 30.29c.The device received alert 11 (patient temperature 1 below low patient alert), alert 51 (patient temperature 1 below control range) and alarm 10 (patient temperature 1 low) multiple times and the device also alerted 51 (patient temperature 1 below control range).The inlet pressure and flow rate were within specification for a neonate.The device heated the patient appropriately and the patient¿s temperature went from 30.29c to 33.5c.The device was functioning properly to maintain the patient at the target.

• Brand Name: ARCTICSUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9781521
• MDR Text Key: 185069639
• Report Number: 1018233-2020-01507
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1