MAUDE Adverse Event Report: DYMAX CORP. -2523003 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM; ARCTIC SUN DEVICE

Catalog Number 5000-00-00

Device Problems Insufficient Cooling (1130); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem Therapeutic Effects, Unexpected (2099)

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 temperature cable was allegedly not working.As a result of the malfunction, the device was replaced with a second arctic sun device.Subsequently, the second device was allegedly unable to cool the patient.At the time of the call to ms&s, the water temperature was 24°c, with good flow, and a patient's temperature was 35.4°c.Upon checking the event log, an alert 113 was noted.The water level was at 4 bars.The nurse refilled the device earlier; however, without emptying the pads.The nurse then drained 500 cc from one drain port, and was only able to get 200 cc from the other drain port.She then put the device into manual mode and set the water temperature to 4°c.After 10 minutes, the water temperature had not changed.Consequently, the device was removed from the patient.The patient was then placed back onto the first arctic sun device with the temperature cable from the second device.The nurse called ms&s again to report that the water temperature was fluctuating.The event log revealed an alert 45 (ac power lost) &114 (therapy stopped for 10 minutes).The nurse placed the device in manual mode, and set the water temperature to 4°c.After 10 minutes, the water temperature was 4.5°c.Therapy was then resumed.One hour later the water temperature was in the 6°c range, and the patient's temperature was down to 34°c.Therapy was resumed on the first device without further issues.

Manufacturer Narrative

The reported issue was confirmed.The device was evaluated by biomedical engineering at the customer facility.The root cause of the reported issue was isolated to a temperature cable failure.The temperature cable was removed from sn (b)(4) and placed onto this device.The biomed confirmed that the device remained in service without further issues.(b)(4).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 evaluated by a biomedical technician at the complainant's facility.

Event Description

It was reported that the temperature cable was allegedly not working.As a result of the malfunction, the device was replaced with a second arctic sun device.Subsequently, the second device was allegedly unable to cool the patient.At the time of the call to (b)(4), the water temperature was 24°c, with good flow, and a patient's temperature was 35.4°c.Upon checking the event log, an alert 113 was noted.The water level was at 4 bars.The nurse refilled the device earlier; however, without emptying the pads.The nurse then drained 500 cc from one drain port, and was only able to get 200 cc from the other drain port.She then put the device into manual mode and set the water temperature to 4°c.After 10 minutes, the water temperature had not changed.Consequently, the device was removed from the patient.The patient was then placed back onto the first arctic sun device with the temperature cable from the second device.The nurse called (b)(4) again to report that the water temperature was fluctuating.The event log revealed an alert 45 (ac power lost) &114 (therapy stopped for 10 minutes).The nurse placed the device in manual mode, and set the water temperature to 4°c.After 10 minutes, the water temperature was 4.5°c.Therapy was then resumed.One hour later the water temperature was in the 6°c range, and the patient's temperature was down to 34°c.Therapy was resumed on the first device without further issues.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6308631
• MDR Text Key: 67157577
• Report Number: 1018233-2017-00331
• 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: 04/27/2017

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: 5000-00-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2011
• 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): Required Intervention