MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES; ARCTIC SUN FLUID DELIVERY LINE

Model Number 60000000

Device Problem Fracture (1260)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

It was reported that they were getting a low air leak message on the arctic sun device.Therapy was currently stopped.The system hours were 975 and pump hours were 940.Nurse disconnected and reconnected pads using proper technique and started therapy.The flow was 1.4lpm, inlet pressure was -2.7psi, circulation pump was 100 percentage.Nurse stopped therapy, disconnected pads, and started therapy in manual mode.The flow was 1.9lpm, inlet pressure was -7.3psi, circulation pump was 48 percentage.Mis asked nurse to inspect the fluid delivery line.Nurse noticed a chunk of one of the o-rings is missing.Nurse connected pads avoiding the damaged valve set.The flow was 3.1lpm, inlet pressure was -7.2psi.Nurse placed device back in automatic mode.Mis asked nurse to tape over, or notate the damaged valve set in some manner, and let biomed know it needs to be repaired.

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 they were getting a low air leak message on the arctic sun device.Therapy was currently stopped.The system hours were 975 and pump hours were 940.Nurse disconnected and reconnected pads using proper technique and started therapy.The flow was 1.4lpm, inlet pressure was -2.7psi, circulation pump was 100 percentage.Nurse stopped therapy, disconnected pads, and started therapy in manual mode.The flow was 1.9lpm, inlet pressure was -7.3psi, circulation pump was 48 percentage.Mis asked nurse to inspect the fluid delivery line.Nurse noticed a chunk of one of the o-rings is missing.Nurse connected pads avoiding the damaged valve set.The flow was 3.1lpm, inlet pressure was -7.2psi.Nurse placed device back in automatic mode.Mis asked nurse to tape over, or notate the damaged valve set in some manner, and let biomed know it needs to be repaired.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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.The device was not returned.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES
• Type of Device: ARCTIC SUN FLUID DELIVERY LINE
• 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: 16706992
• MDR Text Key: 313183844
• Report Number: 1018233-2023-02414
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• 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: 08/02/2023

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: 60000000
• Device Catalogue Number: 734-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/02/2023
• 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