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

Catalog Number 5000-01-01

Device Problems Device Inoperable (1663); Defective Component (2292)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during completion of the service record investigation for this device, a faulty mixing pump was found.

Manufacturer Narrative

The reported issue of the unit not cooling was confirmed with a functional capacity test.The root cause was isolated to a mixing pump issue; as the circulation pump controls filling/flow.Flow was fine.The tech stated once the parts (pumps) were replaced the unit was retested and cooled to set temperatures.Pump will be replaced during preventative maintenance (pm).Pm was performed.Per the pm procedure; pumps, heater and drain ports were replaced.The device was cleaned and an electrical safety test was performed and passed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.1018233-2018-01882-1.

Event Description

It was reported that during completion of the service record investigation for this device, a faulty mixing pump was found.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 7542189
• MDR Text Key: 109383311
• Report Number: 1018233-2018-01882
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

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 Catalogue Number: 5000-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1