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

Model Number 50000000E

Device Problems Failure to Pump (1502); Computer Operating System Problem (2898)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/03/2023

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 arctic sun device had a mixing pump replaced for not cooling and after biomed replaced it they said that the device failed for error 81 (non-recoverable system error); expected 6, actual 22, chiller temperature (t4) was 6.6 degrees so they have biomed for checking the connector for the mixing pump.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was due to a failed mixing pump.During evaluation, it was confirmed that the mixing pump was preventing the device from cooling.Mixing pump head was replaced.Tank harness t-1 t-2 was off by 8 deg.The device underwent pm servicing while in for repair.Tank harness was replaced.Replaced the circulation pump head.Replaced the heater.Replaced the drain valves and replaced both manifold o-rings on the manifold with new coin cell due to age.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.It is not known if the device was in use on a patient.The device history record review was not required as event was not an out of box failure and therefore is not manufacturing related.The labeling review not performed since the complaint or 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 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the arctic sun device had a mixing pump replaced for not cooling and after biomed replaced it they said that the device failed for error 81 (non-recoverable system error) expected 6 actual 22, chiller temperature (t4) was 6.6 degrees.So, they have biomed for checking the connector for the mixing pump.

• 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: 16196052
• MDR Text Key: 308041716
• Report Number: 1018233-2023-00153
• 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: 07/25/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• 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