MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PADS

Model Number 31707

Device Problem Disconnection (1171)

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

Event Date 03/13/2023

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.

Event Description

It was reported that biomed was helping a nurse troubleshoot an arctic sun device currently on a patient.The device was alarming 02 (low flow).Biomed was asking what they recommend doing.Nurse confirmed they have an adult patient on the device with four pads.Mis informed biomed to recommend making sure the tubing was all straight and there are no kinks or bend in the tubing.Mis then recommend pausing therapy, emptying the pads, and disconnecting the pads.They could then reconnect the pads making sure they were only holding the blue tubing and not the clear plastic connectors.Mis explained that this prevents air from being introduced into the lines which causes low flow.Biomed stated the nurse figured out one of the pads became disconnected and was able to reconnect it and fix the flow rate.

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 biomed was helping a nurse troubleshoot an arctic sun device currently on a patient.The device was alarming 02 (low flow).Biomed was asking what they recommend doing.Nurse confirmed they have an adult patient on the device with four pads.Mis informed biomed to recommend making sure the tubing was all straight and there are no kinks or bend in the tubing.Mis then recommend pausing therapy, emptying the pads, and disconnecting the pads.They could then reconnect the pads, making sure they were only holding the blue tubing and not the clear plastic connectors.Mis explained that this prevents air from being introduced into the lines, which causes low flow.Biomed stated the nurse figured out one of the pads became disconnected and was able to reconnect it and fix the flow rate.Per follow-up information received via phone on 06apr2023, nurse confirmed pads had been sized medium.Therapy was completed.Nurse was unable to provide any further information.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTIC GEL PADS
• 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: 16663234
• MDR Text Key: 313397829
• Report Number: 1018233-2023-02250
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080081
• UDI-Public: (01)00801741080081
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142702
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31707
• Device Catalogue Number: 317-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other