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 12/08/2022

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 arctic sun device was not cooling, chiller temperature (t4) dropping to 4.4.The device was almost due for the 2000 hour preventive maintenance.Per sample evaluation results received on 12dec2022, it was reported that the root cause of the reported issue was a failed mixing pump.The mixing pump would not generate enough pressure at lower speeds to pull water from the main tank into the cooling tank.It was stated that the chiller evaporator outlet tube was expanded during servicing.It was noted that the chiller evaporator outlet tube was replaced.

Event Description

It was reported that the arctic sun device was not cooling, chiller temperature (t4) dropping to 4.4.The device was almost due for the 2000 hour preventive maintenance.Per sample evaluation results received on 12dec2022, it was reported that the root cause of the reported issue was a failed mixing pump.The mixing pump would not generate enough pressure at lower speeds to pull water from the main tank into the cooling tank.It was stated that the chiller evaporator outlet tube was expanded during servicing.It was noted that the chiller evaporator outlet tube was replaced.

Manufacturer Narrative

Upon further review, bd has determined that this mdr is not reportable.H11:section a through f - the information provided by bd 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 bd.

• 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: 16052034
• MDR Text Key: 306520792
• Report Number: 1018233-2022-09844
• 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: 03/16/2023

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: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/21/2023
• 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