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

Model Number 50000000

Device Problems Pumping Problem (3016); Physical Resistance/Sticking (4012)

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

Event Date 03/03/2023

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 by biomed that the arctic sun device failed calibration.Biomed stated it gave an alert 25 (patient temperature 2 out of adjustment range limit).Per follow up information received via email on 19dec2022, there was no patient involvement reported.Biomed would order a new isolation circuit board and replace it onsite.Per follow up information received via email on 27dec2022, biomed stated that the isolation board fixed the initial problem, however, it did not pass calibration due to bad chiller pump not cooling and reservoir fill sensors.Per sample evaluation results received on 03mar2023, it was reported that the root cause of the reported issue was due to a failed mixing pump.A test mixing pump was installed in decontamination for unit to cool.It was stated that the motor had excessive resistance when motor shaft spun by hand.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 performed visual and inspection and determined that the ac cca card and power module had degraded due to electrical overstress.It was noted that the mixing pump motor and circulation pump head were replaced.

Manufacturer Narrative

The reported issue was confirmed.The root cause was isolated to a faulty mixing pump motor.The device was evaluated and the reported issue was confirmed as it was noted that the mixing pump motor had excessive resistance when motor shaft spun by hand.Replaced the mixing pump motor (sn # (b)(6)), with new motor (aa220609-185).The arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.The unit is ready for use.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.A dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.A 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 actual/suspected device was inspected.

Event Description

It was reported by biomed that the arctic sun device failed calibration.Biomed stated it gave an alert 25 (patient temperature 2 out of adjustment range limit).Per follow up information received via email on 19dec2022, there was no patient involvement reported.Biomed would order a new isolation circuit board and replace it onsite.Per follow up information received via email on 27dec2022, biomed stated that the isolation board fixed the initial problem, however, it did not pass calibration due to bad chiller pump not cooling and reservoir fill sensors.Per sample evaluation results received on 03mar2023, it was reported that the root cause of the reported issue was due to a failed mixing pump.A test mixing pump was installed in decontamination for unit to cool.It was stated that the motor had excessive resistance when motor shaft spun by hand.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 performed visual and inspection and determined that the ac cca card and power module had degraded due to electrical overstress.It was noted that the mixing pump motor and circulation pump head were replaced.

• 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: 16610158
• MDR Text Key: 311969741
• Report Number: 1018233-2023-02004
• 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: 07/11/2023

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: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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