MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Model Number 50000000E

Device Problem Nonstandard Device (1420)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported that the arctic sun device was failing calibration for error 103 (switch settings incorrect).Calibration testing unit (ctu) was tried on a different device and worked fine.The device was coming in for isolation circuit card replacement under warranty.Per sample evaluation results received on (b)(6) 2022, it was reported that the hot connection between the main ac power circuit card and the power inlet module shows signs of electrical overstress.Per sample evaluation results received on (b)(6) 2022, it was reported the double bend tube and the chiller evaporator outlet tube were found to be expanded during servicing.It was noted that the double-bend tube and the chiller evaporator outlet tube were replaced.

Manufacturer Narrative

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

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as the event was not reportable.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 error 103 (switch settings incorrect).Calibration testing unit (ctu) was tried on a different device and worked fine.The device was coming in for isolation circuit card replacement under warranty.Per sample evaluation results received on 08sep2022, it was reported that the hot connection between the main ac power circuit card and the power inlet module shows signs of electrical overstress.Per sample evaluation results received on 30sep2022, it was reported the double bend tube and the chiller evaporator outlet tube were found to be expanded during servicing.It was noted that the double-bend tube and the chiller evaporator outlet tube were replaced.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; suite 200; covington 30014
• 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: 15586673
• MDR Text Key: 301554286
• Report Number: 1018233-2022-07761
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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