N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 9862617
- MDR report key
- 9862617
- Report number
- 1018233-2020-01994
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-20
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARCTICSUN 5000 | ARCTIC SUN DEVICE | MEDIVANCE, INC. ? 1725056 | DWJ | 50000000E | 50000000E | NA | * | Y | |||
| 1943458 | ARCTICSUN 5000 | ARCTIC SUN DEVICE | MEDIVANCE, INC. ? 1725056 | DWJ | 50000000E | 50000000E | NA | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-20 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE ARCTICSUN DEVICE DISPLAYED AN ALERT 113 DURING THERAPY. THE PATIENT WAS 37C, THE TARGET WAS 33C, AND THE WATER WAS 30C. THE NURSE WAS ADVISED TO SEND THE DEVICE TO THE BIOMED FOR EVALUATION.
D
Patient 0
IT WAS REPORTED THAT THE ARCTICSUN DEVICE DISPLAYED AN ALERT 113 DURING THERAPY. THE PATIENT WAS 37C, THE TARGET WAS 33C, AND THE WATER WAS 30C. THE NURSE WAS ADVISED TO SEND THE DEVICE TO THE BIOMED FOR EVALUATION.
N
Patient 0
THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE OF THE REPORTED ISSUE COULD BE A FAULTY MIXING PUMP. HOWEVER, THIS CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "REVIEWED BAW28-000770-00, REVISION 9 (ARCTIC SUN 5000 OPERATOR'S MANUAL), WHICH STATES THE FOLLOWING: THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM IS INTENDED FOR MONITORING AND CONTROLLING PATIENT TEMPERATURE. WARNINGS AND CAUTIONS WARNINGS ? DO NOT USE THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM IN THE PRESENCE OF FLAMMABLE AGENTS BECAUSE AN EXPLOSION AND/OR FIRE MAY RESULT. ? DO NOT USE HIGH FREQUENCY SURGICAL INSTRUMENTS OR ENDOCARDIAL CATHETERS WHILE THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM IS IN USE. ? THERE IS A RISK OF ELECTRICAL SHOCK AND HAZARDOUS MOVING PARTS. THERE ARE NO USER SERVICEABLE PARTS INSIDE. DO NOT REMOVE COVERS. REFER SERVICING TO QUALIFIED PERSONNEL. ? POWER CORD HAS A HOSPITAL GRADE PLUG. GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED ?HOSPITAL USE? OR ?HOSPITAL GRADE?. ? WHEN USING THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM, NOTE THAT ALL OTHER THERMAL CONDUCTIVE SYSTEMS, SUCH AS WATER BLANKETS AND WATER GELS, IN USE WHILE WARMING OR COOLING WITH THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM MAY ACTUALLY ALTER OR INTERFERE WITH PATIENT TEMPERATURE CONTROL. ? DO NOT PLACE ARCTICGEL? PADS OVER TRANSDERMAL MEDICATION PATCHES AS WARMING CAN INCREASE DRUG DELIVERY, RESULTING IN POSSIBLE HARM TO THE PATIENT. CAUTIONS ? THIS PRODUCT IS TO BE USED BY OR UNDER THE SUPERVISION OF TRAINED, QUALIFIED MEDICAL PERSONNEL. ? FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, BY OR ON THE ORDER OF A PHYSICIAN. ? USE ONLY DISTILLED OR STERILE WATER. THE USE OF OTHER FLUIDS WILL DAMAGE THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM SYSTEM. ? WHEN MOVING THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM ALWAYS USE THE HANDLE TO LIFT THE CONTROLLER OVER AN OBSTACLE TO AVOID OVER BALANCING. ? THE PATIENT BED SURFACE SHOULD BE LOCATED BETWEEN 30 AND 60 INCHES (75 CM AND 150 CM) ABOVE THE FLOOR TO ENSURE PROPER FLOW AND MINIMIZE RISK OF LEAKS. ? THE CLINICIAN IS RESPONSIBLE TO DETERMINE THE APPROPRIATENESS OF CUSTOM PARAMETERS. WHEN THE SYSTEM IS POWERED OFF, ALL CHANGES TO PARAMETERS WILL REVERT TO THE DEFAULT UNLESS THE NEW SETTINGS HAVE BEEN SAVED AS NEW DEFAULTS IN THE ADVANCED SETUP SCREEN. FOR SMALL PATIENTS (=30 KG) IT IS RECOMMENDED TO USE THE FOLLOWING SETTINGS: WATER TEMPERATURE HIGH LIMIT =40?C (104?F); WATER TEMPERATURE LOW LIMIT =10?C (50 ?F); CONTROL STRATEGY =2. ? THE OPERATOR MUST CONTINUOUSLY MONITOR PATIENT TEMPERATURE WHEN USING MANUAL CONTROL AND ADJUST THE TEMPERATURE OF THE WATER FLOWING THROUGH THE PADS ACCORDINGLY. PATIENT TEMPERATURE WILL NOT BE CONTROLLED BY THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM IN MANUAL CONTROL. ? DUE TO THE SYSTEMS HIGH EFFICIENCY, MANUAL CONTROL IS NOT RECOMMENDED FOR LONG DURATION USE. THE OPERATOR IS ADVISED TO USE THE AUTOMATIC THERAPY MODES (E.G. CONTROL PATIENT, COOL PATIENT, REWARM PATIENT) FOR AUTOMATIC PATIENT TEMPERATURE MONITORING AND CONTROL. ? THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM WILL MONITOR AND CONTROL PATIENT CORE TEMPERATURE BASED ON THE TEMPERATURE PROBE ATTACHED TO THE SYSTEM. THE CLINICIAN IS RESPONSIBLE FOR CORRECTLY PLACING THE TEMPERATURE PROBE AND VERIFYING THE ACCURACY AND PLACEMENT OF THE PATIENT PROBE AT THE START OF THE PROCEDURE. ? MEDIVANCE RECOMMENDS MEASURING PATIENT TEMPERATURE FROM A SECOND SITE TO VERIFY PATIENT TEMPERATURE. MEDIVANCE RECOMMENDS THE USE OF A SECOND PATIENT TEMPERATURE PROBE CONNECTED TO THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM TEMPERATURE 2 INPUT AS IT PROVIDES CONTINUOUS MONITORING AND SAFETY ALARM FEATURES. ALTERNATIVELY, PATIENT TEMPERATURE MAY BE VERIFIED PERIODICALLY WITH INDEPENDENT INSTRUMENTATION. ? THE DISPLAYED TEMPERATURE GRAPH IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO REPLACE STANDARD MEDICAL RECORD DOCUMENTATION FOR USE IN THERAPY DECISIONS. ? PATIENT TEMPERATURE WILL NOT BE CONTROLLED AND ALARMS ARE NOT ENABLED IN STOP MODE. PATIENT TEMPERATURE MAY INCREASE OR DECREASE WITH THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM IN STOP MODE. ? CAREFULLY OBSERVE THE SYSTEM FOR AIR LEAKS BEFORE AND DURING USE. IF THE PADS FAIL TO PRIME OR A SIGNIFICANT CONTINUOUS AIR LEAK IS OBSERVED IN THE PAD RETURN LINE, CHECK CONNECTIONS. IF NEEDED, REPLACE THE LEAKING PAD. LEAKAGE MAY RESULT IN LOWER FLOW RATES AND POTENTIALLY DECREASE THE PERFORMANCE OF THE SYSTEM. ? THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM IS FOR USE ONLY WITH THE ARCTICGEL? PADS. ? THE ARCTICGEL? PADS ARE ONLY FOR USE WITH THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEMS. ? THE ARCTICGEL? PADS ARE NON-STERILE FOR...