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

Catalog Number 50000000

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11: section a through f - the information provided by bd represents all 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 they are getting alert 113 (reduced water temperature control).Target temperature was 36c, patient temperature was 36.7c, water temperature was 28.7c, chiller temperature (t4) was 3.9c, mixing pump command was 100 percentage.Pump hours were 7550, system hours were 8244.8.Explained device needs to go to biomed for repair labeled alert 113, not cooling.They borrowed this device and do not have another device.It was reported that the nurse was cooling first patient on and wanted to confirm they set everything up correctly.Nurse stated that they filled the reservoir then pressed start.The timer shows 3 minutes and was in normothermia.Orders were to cool the patient to 36c, maintain for 24 hours, rewarm at 0.25c/hr to a target of 37c.The arctic sun device gave alert 02 (low flow) just as they stopped therapy.Changed therapy selection to hypothermia.Set device per orders.Disconnected and reconnected pads using proper technique and started cooling.Flow rate (fr) was 2.9lpm, inlet pressure (ip) was -7.2psi, circulation pump command (cpc) was 71 percentage and therapy was resumed.Per sample evaluation results received on (b)(6) 2024, it was reported that the power cord insulation was frayed exposing the inner wires.Tank seals lifted from tank.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 they are getting alert 113 (reduced water temperature control).Target temperature was 36c, patient temperature was 36.7c, water temperature was 28.7c, chiller temperature (t4) was 3.9c, mixing pump command was 100 percentage.Pump hours were 7550, system hours were 8244.8.Explained device needs to go to biomed for repair labeled alert 113, not cooling.They borrowed this device and do not have another device.It was reported that the nurse was cooling first patient on and wanted to confirm they set everything up correctly.Nurse stated that they filled the reservoir then pressed start.The timer shows 3 minutes and was in normothermia.Orders were to cool the patient to 36c, maintain for 24 hours, rewarm at 0.25c/hr to a target of 37c.The arctic sun device gave alert 02 (low flow) just as they stopped therapy.Changed therapy selection to hypothermia.Set device per orders.Disconnected and reconnected pads using proper technique and started cooling.Flow rate (fr) was 2.9lpm, inlet pressure (ip) was -7.2psi, circulation pump command (cpc) was 71 percentage and therapy was resumed.Per sample evaluation results received on (b)(6) 2024, it was reported that the power cord insulation was frayed exposing the inner wires.Tank seals lifted from tank.

• 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
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19086870
• MDR Text Key: 340464992
• Report Number: 1018233-2024-01998
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• 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
• Patient Outcome(s): Other