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

Model Number 50000000

Device Problems Defective Component (2292); Physical Resistance/Sticking (4012)

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

Event Date 02/07/2023

Event Type  malfunction  

Event Description

It was reported that the arctic sun device was sent down from the emergency department (ed) for having an air leak and not cooling.The dean stated that the department lost the fluid delivery line (fdl) after someone tore it.Per follow up information received on (b)(6)2022, the biomed states there was no patient injury and has no further information regarding patient.Biomed ran a calibration on device and passed all the tests did not confirm reported issue.After sending the data files to tech support, it was confirmed device was in need for the 2k pm service they would be sending device in for service.Per sample evaluation results received on (b)(6)2023, the root cause was isolated to a faulty circulation pump.It was reported that the device was unable to cool during therapy and that the fluid delivery line was noted to have a tear in it.It was noted that the torn fluid delivery line was not returned for evaluation.It was stated that the double bend tube, the chiller evaporator outlet tube were expanded.The tank seals were lifted and torn.The mixing pump head motor bearing was seizing.The chiller pump outlet molded tub had a kink causing restricting flow through the cooling system.The flow meter displayed inaccurate readings from a sticking impeller.It was also noted that the double bend tube, chiller evaporator outlet tube and tank seals were replaced.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported issue was confirmed.The root cause was isolated to a faulty flow meter.The device was evaluated and the reported issue was confirmed as it was noted that the flow meter displayed inaccurate readings from a sticking impeller.The flow meter was replaced.Dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Therefore, labeling review was not required.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 actual/suspected device was inspected.

Event Description

It was reported that the arctic sun device was sent down from the emergency department (ed) for having an air leak and not cooling.The dean stated that the department lost the fluid delivery line (fdl) after someone tore it.Per follow up information received on 15-aug-2022, the biomed states there was no patient injury and has no further information regarding patient.Biomed ran a calibration on device and passed all the tests did not confirm reported issue.After sending the data files to tech support, it was confirmed device was in need for the 2k pm service they would be sending device in for service.Per sample evaluation results received on 07-feb-2023, the root cause was isolated to a faulty circulation pump.It was reported that the device was unable to cool during therapy and that the fluid delivery line was noted to have a tear in it.It was noted that the torn fluid delivery line was not returned for evaluation.It was stated that the double bend tube, the chiller evaporator outlet tube were expanded.The tank seals were lifted and torn.The mixing pump head motor bearing was seizing.The chiller pump outlet molded tub had a kink causing restricting flow through the cooling system.The flow meter displayed inaccurate readings from a sticking impeller.It was also noted that the double bend tube, chiller evaporator outlet tube and tank seals were replaced.

• 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: 16452074
• MDR Text Key: 310337455
• Report Number: 1018233-2023-01278
• 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: 05/03/2023

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: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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