MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS

Device Problem Moisture Damage (1405)

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

Event Date 04/10/2023

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 called to verify the arctic sun device was working correctly.Started therapy around 4.Targeted temperature (tt) was 33c, patient temperature (pt) was 34c water temperature (wt) was 11.1c, water flow rate (wfr) was 2.6 l/m and 4 pads connected.Condensation noted on pad lines.Nurse denied any shivering, microshivering or seizure activity.Confirmed there was exposed abdomen.Encouraged nurse to add a universal pad to the abdomen for additional coverage and assistance with cooling patient.Noted device was making cold water and appears to be working appropriately.Explained surface area coverage was crucial for temperature management and abdomen holds heat.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "material selection allowing excessive condensation to form".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and lot number for this device were unknown.Therefore, bard was unable to determine the associated labeling to review.H11: section a through f - the information provided by bard represents all of 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 bard.

Event Description

It was reported that the nurse called to verify the arctic sun device was working correctly.Started therapy around 4.Targeted temperature (tt) was 33c, patient temperature (pt) was 34c water temperature (wt) was 11.1c, water flow rate (wfr) was 2.6 l/m and 4 pads connected.Condensation noted on pad lines.Nurse denied any shivering, microshivering or seizure activity.Confirmed there was exposed abdomen.Encouraged nurse to add a universal pad to the abdomen for additional coverage and assistance with cooling patient.Noted device was making cold water and appears to be working appropriately.Explained surface area coverage was crucial for temperature management and abdomen holds heat.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTICGEL 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: 16832601
• MDR Text Key: 314186341
• Report Number: 1018233-2023-02998
• 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
• Report Date: 09/18/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/19/2023
• 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