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

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported that the low flow was observed, with flow rate as 1.0l/m in the arctic sun device when they came back.The patient put back an old machine with new pads.Unfortunately, they only had large pads left and patient needed small pads.The nurse only hooked up one pad.Mss explained that the machine would recognize it as not having enough patient coverage.Nurse ended up connecting additional pads and draping the pads over the patient¿s legs.Nurse stated that the flow was now good.Mss instructed nurse to keep an eye of the water temperature.Nurse was given the field assurance number in case they need it to return the first set of pads that were not working after patient came back from the computed tomography.

Manufacturer Narrative

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

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 low flow was observed, with flow rate as 1.0l/m in the arctic sun device when they came back.The patient put back an old machine with new pads.Unfortunately, they only had large pads left and patient needed small pads.The nurse only hooked up one pad.Mss explained that the machine would recognize it as not having enough patient coverage.Nurse ended up connecting additional pads and draping the pads over the patient¿s legs.Nurse stated that the flow was now good.Mss instructed nurse to keep an eye of the water temperature.Nurse was given the field assurance number in case they need it to return the first set of pads that were not working after patient came back from the computed tomography.Per follow up information received on 29dec2021, user stated that the pads were thrown away and a new set of pads was used.And user stated no patient injury to the patient.

Event Description

It was reported that the low flow was observed, with flow rate as 1.0l/m in the arctic sun device when they came back.The patient put back an old machine with new pads.Unfortunately, they only had large pads left and patient needed small pads.The nurse only hooked up one pad.Mss explained that the machine would recognize it as not having enough patient coverage.Nurse ended up connecting additional pads and draping the pads over the patient¿s legs.Nurse stated that the flow was now good.Mss instructed nurse to keep an eye of the water temperature.Nurse was given the field assurance number in case they need it to return the first set of pads that were not working after patient came back from the computed tomography.Per follow up information received on 29dec2021, user stated that the pads were thrown away and a new set of pads was used.And user stated that there was no injury to the patient.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be, "belt temperatures too low after nip roller and heated section." it was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.T the device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.The device was not returned.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: UNKNOWN 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13088256
• MDR Text Key: 282979426
• Report Number: 1018233-2021-08436
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• 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: 02/24/2022
• 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