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

Model Number 50000000

Device Problem Nonstandard Device (1420)

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

Event Date 07/13/2022

Event Type  malfunction  

Event Description

It was reported that biomed was troubleshooting for calibration error 2 (pre-warm inlet pressure error) on the arctic sun device.Actual value was 0 and expected value was 7.Per follow up information received on 18-jan-2022, biomed stated that the device was not being used on a patient as the problem was found during the preventive maintenance and the device would be sent in for repair.Per sample evaluation result received on 20-apr-2022, it was reported that the patient temperature 1 connection to the isolation circuit card had two broken solder connections leading to intermittent patient temperature readings.The device short filled once.The circulation pump had to be primed to complete autofill.The outer shell with louvers was missing a retaining bolt nut plate that holds the shell to the chiller frame.Per sample evaluation result received on 13-jul-2022, it was noted that tank seals were lifted and teared during repairs.It was stated that the double bend tube and evaporator output l tube were expanded.It was also noted that the flowmeter impeller turned but was a little sticky.

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 biomed was troubleshooting for calibration error 2 (pre-warm inlet pressure error) on the arctic sun device.Actual value was 0 and expected value was 7.Per follow up information received on 18-jan-2022, biomed stated that the device was not being used on a patient as the problem was found during the preventive maintenance and the device would be sent in for repair.Per sample evaluation result received on 20-apr-2022, it was reported that the patient temperature 1 connection to the isolation circuit card had two broken solder connections leading to intermittent patient temperature readings.The device short filled once.The circulation pump had to be primed to complete autofill.The outer shell with louvers was missing a retaining bolt nut plate that holds the shell to the chiller frame.Per sample evaluation result received on 13-jul-2022, it was noted that tank seals were lifted and teared during repairs.It was stated that the double bend tube and evaporator output l tube were expanded.It was also noted that the flowmeter impeller turned but was a little sticky.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as the event was not reportable.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: 15124506
• MDR Text Key: 304720280
• Report Number: 1018233-2022-05844
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: No
• 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