MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTIC SUN 5000, 115V NA; ARCTIC SUN DEVICE

Catalog Number 5000-00-00

Device Problems Break (1069); Material Frayed (1262); Leak/Splash (1354)

Patient Problem No Information (3190)

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.The device was not returned.

Event Description

It was reported that the device was leaking from the right drain port.The nurse received the patient from the er.She reported that the device was empty and that the fill tube was connected to both drain ports.She removed the fill tube from both drain ports and both ports started draining.She then pushed the fill tube into both ports to see if the valve was stuck open.The left port stopped draining, however the right port continued to drain.Another device was not readily available, so the nurse connected the fill tube to both drain ports and clamped it in the middle.She used a second fill tube to refill the device.The nurse reported that they were borrowing a device from (b)(6).When it arrived she moved the patient to the borrowed device.She then reported that the pads that were placed in the er appeared to be damaged.She stated that the blue foam was peeling off near the connectors and "appears as if they were exposed to too much sun".She was not able to provide a lot number.She was asked to save the pads and confirmed that she would.The nurse was not in the room to provide additional information regarding patient temperature, water temperature, or flow rate.During a follow up call later that afternoon, the charge nurse confirmed that the patient had been swapped to the borrowed device.The patient temperature was at 34.6c with a water temperature of 12.1c, and a flow rate of 1.9 liters per minute.She then disconnected/reconnected the pads and the flow rate stabilized at 2.5lpm.The nurse decided to continue to use the pads as they were providing optimal flow.She stated that the foam was a bit frayed on the end.The charge nurse was also advised to save the pads.Per follow up, the patient was able to resume therapy with the same set of pads without any further issues.Per follow up with the biomed on 08/17/2017, it was determined that the chiller on the device was faulty.The device was returned for a replacement chiller and the pm program.

Manufacturer Narrative

Per additional information from the investigation, it was determined that the initial reported event (pumping issue) was against a different device which was captured under a separate complaint.Therefore, this event was determined to be non-reportable.

Event Description

It was reported that the device was leaking from the right drain port.The nurse received the patient from the er.She reported that the device was empty and that the fill tube was connected to both drain ports.She removed the fill tube from both drain ports and both ports started draining.She then pushed the fill tube into both ports to see if the valve was stuck open.The left port stopped draining, however the right port continued to drain.Another device was not readily available, so the nurse connected the fill tube to both drain ports and clamped it in the middle.She used a second fill tube to refill the device.The nurse reported that they were borrowing a device from (b)(6).When it arrived she moved the patient to the borrowed device.She then reported that the pads that were placed in the er appeared to be damaged.She stated that the blue foam was peeling off near the connectors and "appears as if they were exposed to too much sun".She was not able to provide a lot number.She was asked to save the pads and confirmed that she would.The nurse was not in the room to provide additional information regarding patient temperature, water temperature, or flow rate.During a follow up call later that afternoon, the charge nurse confirmed that the patient had been swapped to the borrowed device.The patient temperature was at 34.6c with a water temperature of 12.1c, and a flow rate of 1.9 liters per minute (lpm).She then disconnected/reconnected the pads and the flow rate stabilized at 2.5lpm.The nurse decided to continue to use the pads as they were providing optimal flow.She stated that the foam was a bit frayed on the end.The charge nurse was also advised to save the pads.Per follow up, the patient was able to resume therapy with the same set of pads without any further issues.Per follow up with the biomed on 08/17/2017 it was determined that the chiller on the device was faulty.Per additional follow up the device that failed calibration and was sent back for a chiller failure was sn# (b)(4).The device was returned for a replacement chiller and the preventative maintenance (pm) program.

• Brand Name: ARTIC SUN 5000, 115V NA
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6847750
• MDR Text Key: 85767314
• Report Number: 1018233-2017-04658
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5000-00-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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