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

Model Number 50000000E

Device Problems Insufficient Flow or Under Infusion (2182); Defective Component (2292)

Patient Problems No Consequences Or Impact To Patient (2199); 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 device was not returned.

Event Description

It was reported that the arctic sun device was getting low flow alarms and the clinical staff was not able to get flow to the pads. A functional test showed that the circulation pump would not generate pressure at -7. 0 in bypass and requested for 2000 hour service package. Per additional information received via ttm on 25jun2020, the nurse stated device showed full reservoir, they attached pads and attempted to start therapy, but no flow received. Device sounds like it is running, but no flow to pads. Flow rate was 0. 0 l/m. Device screen said filling device. They disconnected and reconnected pads with no change so they swapped out devices and continued therapy on new device. Ms&s verified fluid delivery line connection was secure and that they were not attempting to fill the device with the pads on. Ms&s told nurse to send device to biomed. As per the follow up information, the biomed stated that the device was fixed (did not state how device was fixed). Device was back in service.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10290105
• MDR Text Key: 200222324
• Report Number: 1018233-2020-04632
• Device Sequence Number: 1
• Product Code: DWJ
• 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: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse