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

Model Number 50000000

Device Problems Failure to Pump (1502); Failure to Calibrate (2440)

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

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the arctic sun device was failing calibration for an error 80 (water check time out ¿ unable to reach calibration temperature).A check of the diagnostics showed that the mixing pump had failed.Biomed requested a quote for the 2000 hours preventive maintenance service.As per follow up information received on (b)(6)2022, there was no patient involvement as it was found during calibration.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is a failed mixing pump.A check of the diagnostics showed that the mixing pump had failed.Biomed requested a quote for the 2000 hours preventive maintenance service.It was known that the device did not meet specifications and that the device was influenced by the reported failure.The device was not in use on a patient.The dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.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 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 device was not returned.

Event Description

It was reported that the arctic sun device was failing calibration for an error 80 (water check time out ¿ unable to reach calibration temperature).A check of the diagnostics showed that the mixing pump had failed.Biomed requested a quote for the 2000 hours preventive maintenance service.As per follow up information received on 30sep2022, there was no patient involvement as it was found during calibration.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue was unable to be determined, as the reported issue could not be duplicated during evaluation.During evaluation, it was found that the error did not reappear on the device. it is unknown if the device was influenced by the reported failure, however the device met specifications during evaluation.The device was not in use on a patient.A dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.As the reported event is unconfirmed, labeling review is not required.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 evaluated.

Event Description

It was reported that the arctic sun device was failing calibration for an error 80 (water check time out ¿ unable to reach calibration temperature).A check of the diagnostics showed that the mixing pump had failed.Biomed requested a quote for the 2000 hours preventive maintenance service.As per follow up information received on 30sep2022, there was no patient involvement as it was found during calibration.Per sample evaluation results received on 12apr2023, it was reported that the pem missing from shell.It was stated that the l-tube and double l-tubing appeared distended or expanded however water flow was not impeded, it would be replaced preventatively.It was also stated that the performed visual and inspection and determined that the ac cca card and power module has degraded due to electrical overstress and will be replaced preventatively.It was noted that the scratches on control panel screen and this had no effect on the operation of the control panel.It was also noted that that the replaced the tank tubing, power inlet module, and cca ca card.

• 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: 15596089
• MDR Text Key: 306704019
• Report Number: 1018233-2022-07806
• 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,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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