MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number 50000000

Device Problems Circuit Failure (1089); Overheating of Device (1437)

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

Event Date 03/14/2024

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 had the artic sun device that was not cooling they tried to do the calibration and it failed for an error 80(water check time out - unable to reach calibration temperature) for not cooling, confirmed mixing pump had failed and the device was due for the 2000-hour preventive maintenance, sending quote for service.Per sample evaluation results on (b)(6) 2024, it was reported that the hot side connection between the ac main voltage circuit card and the power inlet module shows signs of electrical overstress.Tanks seals had dry rot and cracking.Mixing pump motor had bearing that was seizing.

Event Description

It was reported that biomed had the artic sun device that was not cooling they tried to do the calibration and it failed for an error 80(water check time out - unable to reach calibration temperature) for not cooling, confirmed mixing pump had failed and the device was due for the 2000-hour preventive maintenance, sending quote for service.Per sample evaluation results on 14mar2024, it was reported that the hot side connection between the ac main voltage circuit card and the power inlet module shows signs of electrical overstress.Tanks seals had dry rot and cracking.Mixing pump motor had bearing that was seizing.

Manufacturer Narrative

The reported issue was confirmed.It was concluded that the following was the root cause: supplier ¿ root cause o inadequate verification and validation activities of the crimping process o single pull test did not provide stability of process o evidence was not provided when requested for maintenance of records or crimp tools o no crimp cross-sections provided.A dhr review is not required.A labeling review is not required because labeling could not have prevented this issue.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.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: ARCTIC SUN DEVICE
• 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: 19031312
• MDR Text Key: 339227972
• Report Number: 1018233-2024-01803
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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: 04/18/2024

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 Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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