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

Model Number 50000000

Device Problem Overheating of Device (1437)

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

Event Date 02/22/2023

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 biomed had a arctic sun device that failed the calibration for an error 80 (non-recoverable system error) expected 6 actual 20, biomed ordered a mixing pump and would replace in biomed.Per work order reviewed on 15nov2022, the biomed replaced the mixing pump but device still did not pass calibration expected 6 actual 6.27.Biomed sending device in for evaluation.Per sample evaluation results received on 22feb2023, the root cause of the reported issue was due to a failed tank harness.It was reported that the double bend tube found 1/2 way installed into tank and expanded as was the chiller outlet tube to the tank.It was stated that the tank seals were found to be lifted from the tank and no longer properly sealing.It was also stated that device leaked around chiller tubes due to the seals no longer sealing the tank around the tubes.The hot side connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.It was noted that replaced the tank seals, double bend, and chiller evaporator outlet tubes due to expansion.It was also noted that preventatively replaced the power inlet module and ac main voltage circuit card.

Event Description

It was reported that the biomed had a arctic sun device that failed the calibration for an error 80 (non-recoverable system error) expected 6 actual 20, biomed ordered a mixing pump and would replace in biomed.Per work order reviewed on 15nov2022, the biomed replaced the mixing pump but device still did not pass calibration expected 6 actual 6.27.Biomed sending device in for evaluation.Per sample evaluation results received on 22feb2023, it was reported that the root cause of the reported issue was due to a failed tank harness.It was stated that the double bend tube found 1/2 way installed into tank and expanded as was the chiller outlet tube to the tank.It was also stated that the tank seals were found to be lifted from the tank and no longer properly sealing.It was noted that device leaked around chiller tubes due to the seals no longer sealing the tank around the tubes.The hot side connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.It was noted that replaced the tank seals, double bend, and chiller evaporator outlet tubes due to expansion.It was also noted that the preventatively replaced the power inlet module and ac main voltage circuit card.

Manufacturer Narrative

The reported issue was confirmed.The device was evaluated upon receipt.The hot side connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.Replaced power inlet module and ac main voltage circuit card.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.Root cause -inadequate verification and validation activities of the crimping process, single pull test did not provide stability of process, evidence was not provided when requested for maintenance of records or crimp tools, no crimp cross-sections provided.The dhr review is not required and the risk review and labeling review is not required as the investigation was confirmed related to supplier 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.H3 other text: the actual/suspected device was inspected.

• 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: 16545504
• MDR Text Key: 311383680
• Report Number: 1018233-2023-01758
• 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,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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