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 07/18/2022

Event Type  malfunction  

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 nurse was seeing zero flow on arctic sun device.A functional check showed the arctic sun device would not generate any inlet pressure at all even with a circulation pump command of 100 percentage.Mss discussed this was indicative of a failed circulation pump.Mss stated that they would discuss repair options with management and get back to us.Per additional information received via follow-up on 07-feb-2022, it was stated that there was no patient involvement and device had a failed circulation pump.Per sample evaluation, it was reported that the arctic sun device was not cooling.A test mixing pump was installed to pass decontamination.Per sample evaluation results received on 18-jul-2022, it was noted that the double bend tube and chiller evaporator outlet tube were found expanded during repairs.

Event Description

It was reported that the nurse was seeing zero flow on arctic sun device.A functional check showed the arctic sun device would not generate any inlet pressure at all even with a circulation pump command of 100 percentage.Mss discussed this was indicative of a failed circulation pump.Mss stated that they would discuss repair options with management and get back to us.Per additional information received via follow-up on 07-feb-2022, it was stated that there was no patient involvement and device had a failed circulation pump.Per sample evaluation, it was reported that the arctic sun device was not cooling.A test mixing pump was installed to pass decontamination.Per sample evaluation results received on 18-jul-2022, it was noted that the double bend tube and chiller evaporator outlet tube were found expanded during repairs.

Manufacturer Narrative

Upon further review, bd has determined that this event is not reportable.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 inspected.

• 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: 15139789
• MDR Text Key: 304843127
• Report Number: 1018233-2022-05940
• 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: 01/25/2023

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 Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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