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

Catalog Number 50000000

Device Problems Insufficient Heating (1287); Overfill (2404)

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

Event Date 03/04/2024

Event Type  malfunction  

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.H3 other text : the device was not returned.

Event Description

It was reported that the biomed was at the bedside.They have a patient on the arctic sun device, the nurses were getting an alarm 113 (reduced water temperature control) on a device.Confirmed rewarming box flashing, targeted temperature (tt) was 37c, patient temperature (pt) was 33.7c, water flow rate (wfr) was 2.9 l/min, water temperature (wt) was 31.1c.Diagnostics showed that the outlet monitor temperature (t1) was 30.6c, outlet control temperature (t2) was 31c, inlet temperature (t3) was 30.5c, chiller temperature (t4) was 8c, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 66 percentage, mixing pump command (mpc) was 0 percentage, heater command (hc) was 100 percentage, water reservoir level (wrl) was 5, system hours were 2,570, and pump hours were 2,424.Walked biomed through draining 500 ml from the right drain port.Water temperature began increasing, up to 35.2c at end of call.Informed biomed to have nurses call back if the alarm returned or patient did not begin to rewarm as it was programmed.

Manufacturer Narrative

Per investigational findings, bd has determined that this mdr as not reportable as the reported event was confirmed as user related.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.H3 other text : the device was not returned.

Event Description

It was reported that the biomed was at the bedside.They have a patient on the arctic sun device, the nurses were getting an alarm 113 (reduced water temperature control) on a device.Confirmed rewarming box flashing, targeted temperature (tt) was 37c, patient temperature (pt) was 33.7c, water flow rate (wfr) was 2.9 l/min, water temperature (wt) was 31.1c.Diagnostics showed that the outlet monitor temperature (t1) was 30.6c, outlet control temperature (t2) was 31c, inlet temperature (t3) was 30.5c, chiller temperature (t4) was 8c, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 66 percentage, mixing pump command (mpc) was 0 percentage, heater command (hc) was 100 percentage, water reservoir level (wrl) was 5, system hours were 2,570, and pump hours were 2,424.Walked biomed through draining 500 ml from the right drain port.Water temperature began increasing, up to 35.2c at end of call.Informed biomed to have nurses call back if the alarm returned or patient did not begin to rewarm as it was programmed.Per biomed tech via phone on (b)(6), 2024, it was reported that the device needs a logic board.It has already been ordered and waiting for its arrival.

• 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: 18967444
• MDR Text Key: 338487338
• Report Number: 1018233-2024-01529
• 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: 04/02/2024

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 Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/03/2024
• 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