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

Model Number 50000000E

Device Problem Computer Software Problem (1112)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

It was reported that while doing incoming inspection, the hospital asset numbers on the front shell showed that the panels were installed onto the wrong arctic sun devices (#(b)(4)) (#(b)(4)).Biomed had two arctic sun devices which was sent for the 2k hour preventive maintenance.Another observation was the system and pump hours on both devices did not line up with what they left with (#(b)(4)) (#(b)(4)).

Manufacturer Narrative

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

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 while doing incoming inspection, the hospital asset numbers on the front shell showed that the panels were installed onto the wrong arctic sun devices (b)(4).Biomed had two arctic sun devices which was sent for the 2k hour preventive maintenance.Another observation was the system and pump hours on both devices did not line up with what they left with(b)(4).

Manufacturer Narrative

The reported issue was unconfirmed.No root cause was able to be determined as the device met specifications during evaluation.The device was evaluated and the reported issue was not able to be confirmed as the issue was not found during inspection.No repairs were needed.Device was put through a functional check.The device was heated to 42°c and cooled to 4°c and was stable at 28°c with a flow of 1.8 l/m with -7.0 psi in bypass mode.The device was placed on automated calibration and test system (acats).An electrical safety test was performed.A final inspection was performed.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.The device history record review and labeling review was not required as the reported event was unconfirmed.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.

Event Description

It was reported that while doing incoming inspection, the hospital asset numbers on the front shell showed that the panels were installed onto the wrong arctic sun devices.Biomed had two arctic sun devices which was sent for the 2k hour preventive maintenance.Another observation was the system and pump hours on both devices did not line up with what they left with.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13619356
• MDR Text Key: 286249025
• Report Number: 1018233-2022-00918
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• 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: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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