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

Catalog Number 60000000

Device Problems Circuit Failure (1089); Failure to Calibrate (2440)

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

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is a failed pressure transducer.The device was evaluated upon receipt.The reported issue of device returning to service depot was confirmed incorrect psi.Replaced manifold transducer.The arctic sun stat passed all performance testing, and electrical safety tests and is functioning properly and ready for use.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review is not required as 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.

Event Description

It was reported that the arctic sun device was failing calibration for low flow.A check of the diagnostics showed that inlet pressure (ip) read -5.0 even with the fluid delivery line (fdl) removed, resulting in low bypass flow.They stated a loaner would be shipped out overnight and this device would be returned for service.

Manufacturer Narrative

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

Event Description

It was reported that the arctic sun device was failing calibration for low flow.A check of the diagnostics showed that inlet pressure (ip) read -5.0 even with the fluid delivery line (fdl) removed, resulting in low bypass flow.They stated a loaner would be shipped out overnight and this device would be returned for service.

• Brand Name: ARCTIC SUN STAT
• 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: 19161076
• MDR Text Key: 341249496
• Report Number: 1018233-2024-02226
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• 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: 04/24/2024

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 Catalogue Number: 60000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2023
• 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