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

Catalog Number 60000000

Device Problem Gas/Air Leak (2946)

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

Event Date 04/07/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.

Event Description

It was reported that they were trying starts therapy on stat dyhxal02.They were getting low flow (02) alerts.They guided to diagnostics system hours 305, pump hours 0, inlet pressure(ip) -12.7psi, circulation pump command (cpc) 0%, flow rate(fr) 0lpm.Dc/rc pads using proper technique.No change in values.Stopped therapy, drained/disconnected pads and connected to sn 1830.The inlet pressure(ip) -7psi, flow rate(fr) 3.2lpm, circulation pump command(cpc) 82%.They would send the stat to biomed.

Event Description

It was reported that they were trying starts therapy on stat dyhxal02.They were getting low flow (02) alerts.They guided to diagnostics system hours 305, pump hours 0, inlet pressure(ip) -12.7psi, circulation pump command (cpc) 0%, flow rate(fr) (b)(4).Dc/rc pads using proper technique.No change in values.Stopped therapy, drained/disconnected pads and connected to sn (b)(6).The inlet pressure(ip) -7psi, flow rate(fr) (b)(6), circulation pump command(cpc) 82%.They would send the stat to biomed.

Manufacturer Narrative

The reported issue was confirmed.The root cause identified is a failed pressure transducer.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Correction- d, f, h.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 actual/suspected device was inspected.

• 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: 19200516
• MDR Text Key: 341984883
• Report Number: 1018233-2024-02342
• 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
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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