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

Model Number 60000000

Device Problems Nonstandard Device (1420); Component Misassembled (4004)

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

Event Date 03/16/2023

Event Type  malfunction  

Event Description

It was reported that the arctic sun device during a functional test was giving a low flow alarm.A check of the diagnostics showed that in bypass the flow was so high that the device thought an external flow path was connected and the bypass vale closed again, and flow dropped to 0.Mis stated would replace the device as an out of box failure.Per sample evaluation results received on (b)(6) 2023, it was reported that the root cause of the reported issue was due to a failed pressure transducer.During testing, it was confirmed that the device received low flow.Manifold transducer controls the inlet pressure causing low and no flow.It was reported that ac cc card needs replaced due to the blue wire jacket.It was noted that pressure transducer and ac cca card were replaced.Per confirmation from technician received on 20mar2023, it was stated that the wire jacket (the protective layer around the bare wires) was thinner than usual.

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.

Manufacturer Narrative

The reported issue was confirmed.The device was evaluated upon receipt.Ac cc card needs replaced due to the blue wire jacket.Per confirmation from technician, it was stated that the wire jacket (the protective layer around the bare wires) was thinner than usual.Ac cca card was replaced.The arctic sun stat passed all performance testing, and electrical safety tests and is functioning properly and ready for use.The most likely root cause of the reported issue is that kimball did not have the proper incoming inspection procedures.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.The dhr review is not required and 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.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 during a functional test was giving a low flow alarm.A check of the diagnostics showed that in bypass the flow was so high that the device thought an external flow path was connected and the bypass vale closed again, and flow dropped to 0.Mis stated would replace the device as an out of box failure.Per sample evaluation results received on (b)(6) 2023, it was reported that the root cause of the reported issue was due to a failed pressure transducer.During testing, it was confirmed that the device received low flow.Manifold transducer controls the inlet pressure causing low and no flow.It was reported that ac cc card needs replaced due to the blue wire jacket.It was noted that pressure transducer and ac cca card were replaced.Per confirmation from technician received on (b)(6) 2023, it was stated that the wire jacket (the protective layer around the bare wires) was thinner than usual.

• 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: 16691382
• MDR Text Key: 312803859
• Report Number: 1018233-2023-02361
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60000000
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• 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