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

Catalog Number 318-02

Device Problems Inaccurate Flow Rate (1249); Deformation Due to Compressive Stress (2889)

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

Event Date 04/09/2021

Event Type  malfunction  

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 the water in arctic sun device did not flow properly from the beginning of use.Mss confirmed that there was a leak at the hose joint of the pad.On the day of the event, brought the replacement pad and pulled it up.When confirmed that it was sold on january 12 and it was a new defect, the hospital nurse had reported that the expiration date had expired and a request for replacement of a new defect was made via store.As per follow up 2 received via ibc on 26apr2021 they think the translator have told the wrong thing.The nurse says ¿within the expiration date¿.

Event Description

It was reported that the water in arctic sun device did not flow properly from the beginning of use.Mss confirmed that there was a leak at the hose joint of the pad.On the day of the event, brought the replacement pad and pulled it up.When confirmed that it was sold on january 12 and it was a new defect, the hospital nurse had reported that the expiration date had expired and a request for replacement of a new defect was made via store.As per follow up 2 received via ibc on 26apr2021 they think the translator have told the wrong thing.The nurse says ¿within the expiration date¿.

Manufacturer Narrative

The reported event was confirmed design related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product¿s design caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), used neonatal pad.Visual inspection of the sample noted that the connector tubing was kinked on the end closer to the gel pad.This does not meet the specification "there should be no bends in the tube that reduce the internal diameter of the hose." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling was not completed as they are addressed by existing capa.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.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTICGEL PAD
• 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: 11784243
• MDR Text Key: 249301020
• Report Number: 1018233-2021-02626
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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 Expiration Date: 08/31/2021
• Device Catalogue Number: 318-02
• Device Lot Number: NGEP0417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• 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