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

Model Number 50000000

Device Problems Decreased Pump Speed (1500); Physical Resistance/Sticking (4012)

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

Event Date 03/17/2023

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 nurse had patient on the arctic sun device.The device was alarming 113 (reduced water temperature control).The target temperature was 34.5c, patient temperature was 34.8c, water temperature was 30.6c and water flow rate was 2.4l/min.Mis walked nurse through accessing the system diagnostics showed outlet monitor temperature (t1) was 30.7c, outlet control temperature (t2) was 30.6c, inlet temperature (t3) was 30.7c, chiller temperature (t4) was 3.9c, mixing pump command was 100 percentage, heater command was 0 percentage, system hours were 7,455 and pump hours were 6,654.Mis explained to nurse it appeared the mixing pump had gone out.Mis informed nurse would need to send this device to biomed labelled 'not cooling'.Nurse would swap to another device.Per sample evaluation results received on 17mar2023, it was reported that the root cause of the reported issue was due to a failed mixing pump.It was stated that the replaced the double bend tube and the chiller evaporator outlet tube due to expansion of the tubes found during servicing.It was also stated that replaced the tank seals due to lifting from the tank.It was noted stated that the circulation pump motor had dried out bearing and broken thrust washer.

Event Description

It was reported that nurse had patient on the arctic sun device.The device was alarming 113 (reduced water temperature control).The target temperature was 34.5c, patient temperature was 34.8c, water temperature was 30.6c and water flow rate was 2.4l/min.Mis walked nurse through accessing the system diagnostics showed outlet monitor temperature (t1) was 30.7c, outlet control temperature (t2) was 30.6c, inlet temperature (t3) was 30.7c, chiller temperature (t4) was 3.9c, mixing pump command was 100 percentage, heater command was 0 percentage, system hours were 7,455 and pump hours were 6,654.Mis explained to nurse it appeared the mixing pump had gone out.Mis informed nurse would need to send this device to biomed labelled 'not cooling'.Nurse would swap to another device.Per sample evaluation results received on (b)(6) 2023, it was reported that the root cause of the reported issue was due to a failed mixing pump.It was stated that the replaced the double bend tube and the chiller evaporator outlet tube due to expansion of the tubes found during servicing.It was also stated that replaced the tank seals due to lifting from the tank.It was noted stated that the circulation pump motor had dried out bearing and broken thrust washer.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was isolated to a failed circulation pump.A device history record review was not required as the device has undergone previous servicing and therefore the reported issue was not manufacturing related.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Hence, a labeling review was not required.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.

• 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: 16700679
• MDR Text Key: 312889082
• Report Number: 1018233-2023-02383
• 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: 08/21/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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