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 08/15/2022

Event Type  malfunction  

Event Description

It was reported that the arctic sun device had a failed mixing pump.The customer requested a quote for the 2000 hours service package.As per follow up information received on (b)(6) 2022 , there was no patient involvement during reported event and the device would be sent in for service and repair.As per sample evaluation results received on (b)(6) 2022 , the arctic sun device was primed to fill.It was noted that double-bent tubes were found during repairs to be expanded.It was also noted that the tank seals were found to be lifted from the tank.

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 failed mixing pump.The customer requested a quote for the 2000 hours service package.As per follow up information received on 08feb2022, there was no patient involvement during reported event and the device would be sent in for service and repair.As per sample evaluation results received on 15aug2022, the arctic sun device was primed to fill.It was noted that double-bent tubes were found during repairs to be expanded.It was also noted that the tank seals were found to be lifted from the tank.Per sample evaluation results received on 31jan2023, the root cause was isolated to a faulty mixing pump.It was reported that the chiller evaporator tank outlet tube was expanded.It was noted that the double bend tube, chiller evaporator tank outlet tube was replaced with five new tank seals.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is 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: 15292724
• MDR Text Key: 305367165
• Report Number: 1018233-2022-06649
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• 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: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• 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