MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE; UNKNOWN ARCTIC SUN TEMPERATURE CABLE

Device Problems Failure to Sense (1559); Device Sensing Problem (2917)

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

Event Date 10/23/2023

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 the nurse stated that neither patient temperature (pt) 1 nor patient temperature (pt) 2 were registering on the arctic sun device.Discussed disconnecting and reconnecting cables.Patient temperature (pt) 1 was now registering.Walked through enabling patient temperature (pt) 2, but nurse stated that they did have it enabled, but disabled to get patient temperature (pt) 1 to work.Advised patient temperature (pt) 2 should not affect patient temperature (pt) 1 registering.Encouraged to enable patient temperature (pt) 2, but nurse stated that they have patient temperature (pt) 1 registering so they were not concerned.Noted patient temperature (pt) 2 still not registering they could try replacing the temperature cable.

Manufacturer Narrative

Upon further review, bd has determined that this mdr 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.H3 other text : the device was not returned.

Event Description

It was reported that the nurse stated that neither patient temperature (pt) 1 nor patient temperature (pt) 2 were registering on the arctic sun device.Discussed disconnecting and reconnecting cables.Patient temperature (pt) 1 was now registering.Walked through enabling patient temperature (pt) 2, but nurse stated that they did have it enabled, but disabled to get patient temperature (pt) 1 to work.Advised patient temperature (pt) 2 should not affect patient temperature (pt) 1 registering.Encouraged to enable patient temperature (pt) 2, but nurse stated that they have patient temperature (pt) 1 registering so they were not concerned.Noted patient temperature (pt) 2 still not registering they could try replacing the temperature cable.Per follow up information received via phone on 26dec2023, spoke with nurse who noted a biomed came to the unit and replaced the temperature cable.After replacement, therapy completed with no further issues.The cable was disposed of.

• Brand Name: UNKNOWN ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Type of Device: UNKNOWN ARCTIC SUN TEMPERATURE CABLE
• 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: 18147731
• MDR Text Key: 328262588
• Report Number: 1018233-2023-08155
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• 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