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

Model Number 50000000E

Device Problems Failure to Pump (1502); Physical Resistance/Sticking (4012)

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

Event Date 04/12/2023

Event Type  malfunction  

Event Description

It was reported that the biomed stated the arctic sun device was not cooling, checked the chiller tank and it was at 4 degrees, found the mixing pump not to be working, device has 4108 and biomed would do the 2000 hour pm.Per sample evaluation results received on 12apr2023.It was reported that the mixing pump would not generate sufficient pressure to draw water into the chiller tank.It was stated that this determination was concluded by examination of the patient data attached to the notes section.T4 (chiller temperature) was noted to be 4 degrees c.It was also stated that the arctic sun device failed to complete autofill cycle until the circulation pump was primed with water.It was stated that the double bend tube and chiller evaporator tube found expanded during servicing.It was also stated that the circulation pump motor had dried out squeaky bearings.It was noted that the replaced the double bend tube, chiller evaporator outlet tube and circulation pump motor.

Manufacturer Narrative

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

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is a failed circulation pump motor.The device was evaluated upon receipt.It was confirmed that the that the circulation pump motor had dried out squeaky bearings.Circulation pump motor was replaced.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.A dhr is not required as this is not an out-of-box failure.The reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.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.

Event Description

It was reported that the biomed stated the arctic sun device was not cooling, checked the chiller tank and it was at 4 degrees, found the mixing pump not to be working, device has 4108 and biomed would do the 2000 hour pm.Per sample evaluation results received on 12apr2023, it was reported that the mixing pump would not generate sufficient pressure to draw water into the chiller tank.It was stated that this determination was concluded by examination of the patient data attached to the notes section.T4 (chiller temperature) was noted to be 4 degrees c.It was also stated that the arctic sun device failed to complete autofill cycle until the circulation pump was primed with water.It was stated that the double bend tube and chiller evaporator tube found expanded during servicing.It was also stated that the circulation pump motor had dried out squeaky bearings.It was noted that the replaced the double bend tube, chiller evaporator outlet tube and circulation pump motor.

• 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: 16885386
• MDR Text Key: 314723318
• Report Number: 1018233-2023-03207
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 08/08/2023

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
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2018
• 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