ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Report
- Report Number
- 1018233-2025-06941
- Event Type
- Malfunction
- Date Received
- August 21, 2025
- Date of Event
- August 14, 2025
- Report Date
- October 31, 2025
- Manufacturer
- MEDIVANCE, INC. ¿ 1725056
- Product Code
- DWJ
- UDI-DI
- 00801741132131
- PMA / PMN Number
- K142702
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED, AS THE ISSUE COULD NOT BE DUPLICATED DURING EVALUATION. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED ARCTIC GEL NEONATAL PAD PRESENT WITH NO ORIGINAL PACKAGING. FIVE PHOTOS WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED THE FOLLOWING: * NO OBVIOUS VISIBLE DEFECTS SUCH AS CUTS OR TEARS IN THE FOAM. * NO VISIBLE CHIPS OR DEFORMITIES AT THE ENDS OF ALL CONNECTORS. * MAJOR KINKS WERE SEEN IN THE LINES ON ONE SIDE OF THE PAD THAT AFFECTED FLOW RATE WHEN THE LINES WERE MOVED. PR# (B)(4) WAS OPENED TO CAPTURE THIS FINDING. * HYDROGEL WAS INTACT WITH PAD AND NOT SEPARATED. THE NONWOVEN TAPE LAYER WAS INTACT AND NO HYDROGEL WAS SEEN ON THE OUTSIDE OF THE PHYSICAL SAMPLE. THE RETURNED PHOTOS SHOW WHAT APPEARS TO BE BITS OF HYDROGEL ON THE PAD AND ADHERED TO THE PATIENT'S SKIN AS WELL AS AN ELECTRICAL CABLE. * NO CRUSHED DIMPLES OR SIGNS OF OVERLAMINATION IN THE PAD. THE LABELING/PACKAGING REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. A DHR REVIEW IS NOT REQUIRED AS THE LOT NUMBER IS UNKNOWN. NO ADDITIONAL ACTIONS ARE REQUIRED. CORRECTION: D, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID.H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.
IT WAS REPORTED THAT THE STAFF HAVE BROUGHT SOME CONCERNS WITH THE ARCTIC SUN PADS THEY HAVE RECENTLY USED AND WANTED TO REACH OUT FOR THEIR INPUT. ON (B)(6) 2025 ONE SEEMED LIKE IT WAS LEAKING. AS FAR AS THEY KNOW NOTHING ALARMED, BUT THERE WAS CONCERN THAT THERE WAS COLD WET MOISTURE ON THE BABY AND THE PAD WAS CHANGED. IT WAS NOTED TO HAVE VERY LOW WATER TEMPERATURES FOR THE 1ST 12 HOURS OF COOLING. MACHINE #1 WAS USED. THEY SWITCHED THE BLANKET AROUND 2300 ON (B)(6). THEY BELIEVE THAT WAS WHEN THEY FELT LIKE THERE WAS COLD MOISTURE ON THE INFANT AND ON THE PAD. AFTER THEY CHANGED OUT THE BLANKET, THE BABY'S TEMPERATURE DECREASED, AND THEY WERE ASSUMING THE NEW PAD SEEMED TO BE WORKING CORRECTLY THEREAFTER. THEY DID KEEP THE PAD THAT THEY THOUGHT MAY HAVE BEEN LEAKING. SHOULD THEY CONNECT IT TO THE MACHINE TO SEE IF IT WAS IN FACT LEAKING. THEY WANT TO CHECK WHETHER THEY HAVE YOU HEARD OF THIS EVER HAPPENING BEFORE. THE SECOND ISSUE WAS ON (B)(6) 2025 AND THE NURSES WERE NOTING THAT THE BABY WAS READING COLD AND THE PAD WAS NOT GETTING WARMER. IT WAS STAYING AROUND 15-20 DEGREES DESPITE THE BABY HAVING AN ESOPHAGEAL TEMPERATURE OF 32.5-32.9 DEGREES. THE DID END UP CHANGING OUT THE PAD OVERNIGHT (ON 7/4) AND THE TEMPERATURE IN THE PAD DID INCREASE AND THE INFANT'S ESOPHAGEAL TEMPERATURE REMAINED WITHIN TARGET FOR THE REMAINDER OF THE THERAPY, BUT IT DID SEEM ODD. IT WAS REPORTED THAT THE COOLING STARTED AROUND 2PM YESTERDAY. THE NIGHT NURSE HAD TO REPLACE THE ARCTIC GEL PAD AROUND 2AM BECAUSE IT WAS WET. THEY DESCRIBED IT AS BUBBLING UP. WHEN THEY CAME ON AT 8AM, THE PAD WAS WET AGAIN. EXPLAINED THE WATER WAS UNDER A VACUUM MEANING THAT IF THERAPY WAS RUNNING AND WATER WAS CIRCULATING, THE WATER COULD NOT LEAK OUT, AIR GETS SUCKED IN. SUGGESTED LOOKING FOR ANOTHER SOURCE OF THE FLUID EXAMPLE URINE, IV FLUID. EXPLAINED THEY COULD PLACE THE PAD BEHIND THE NURSING STATION FOR QUALITY, IF DESIRED. ASKED TO TAKE PICTURES. THE PACKAGING HAS BEEN DISCARDED, NO LOT NUMBER AVAILABLE. CALLED BACK A FEW HOURS LATER AND THE NURSE CALLED LOCAL REPRESENTATIVE WHO TOLD HUP WAS EXPERIENCING THE SAME THING AND IT WAS BEING INVESTIGATED. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 14AUG2025, SPOKE WITH NURSE WHO CONFIRMED THE PAD HAD BEEN LEAKING FLUID. THEY HAD SPOKEN WITH THEIR REPRESENTATIVE WHO CONFIRMED THIS SEEMS TO BE AN ONGOING ISSUE WITH PADS AND THOUGHT IT MIGHT BE DUE TO TRANSPORT IN A HOT VEHICLE BUT COULD NOT CONFIRM. THEY WOULD BE INVESTIGATING THIS. THE INFANT EXPERIENCED REDNESS ON THE SKIN THAT RESOLVED ON ITS OWN WITHOUT INTERVENTION. THERAPY WAS DISCONTINUED DUE TO PAD LEAKING. NO ALTERNATE FORMS OF TREATMENT WERE USED. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS REPORTED THAT THE INFANT WHO STARTED COOLING AT 1400 YESTERDAY, THIS MORNING AT 0200, THE BLANKET WAS SOAKED WITH WATER EXTERNALLY. IT WAS CHANGED, AT 0800 THIS MORNING, THE SAME THING HAPPENED. THE MALFUNCTION OCCURRED TWICE ON ONE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 03SEP2025, SPOKE WITH CHARGE NURSE WHO STATED ALL PADS HAVE BEEN COLLECTED BY THEIR LOCAL REPRESENTATIVE. THERE WERE CURRENTLY NO ADDITIONAL PADS BEING KEPT IN THE OFFICE AND NOTED THAT THEY WERE NOT KEEPING NOTES ON EACH INDIVIDUAL FAULTY PAD CASE AT THIS TIME SINCE THEY HAVE EXPERIENCED SEVERAL PAD ISSUES. THE PAD WAS LIKELY EXCHANGED WITH A NEW ONE BUT COULD NOT CONFIRM. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 27OCT2025, IT WAS REPORTED THAT THE MAJOR KINKS WERE SEEN IN THE LINES ON ONE SIDE OF THE PAD THAT AFFECTED FLOW RATE WHEN THE LINES WERE MOVED.
IT WAS REPORTED THAT THE STAFF HAVE BROUGHT SOME CONCERNS WITH THE ARCTIC SUN PADS THEY HAVE RECENTLY USED AND WANTED TO REACH OUT FOR THEIR INPUT. ON (B)(6) 2025 ONE SEEMED LIKE IT WAS LEAKING. AS FAR AS THEY KNOW NOTHING ALARMED, BUT THERE WAS CONCERN THAT THERE WAS COLD WET MOISTURE ON THE BABY AND THE PAD WAS CHANGED. IT WAS NOTED TO HAVE VERY LOW WATER TEMPERATURES FOR THE 1ST 12 HOURS OF COOLING. MACHINE #1 WAS USED. THEY SWITCHED THE BLANKET AROUND 2300 ON (B)(6) 2025. THEY BELIEVE THAT WAS WHEN THEY FELT LIKE THERE WAS COLD MOISTURE ON THE INFANT AND ON THE PAD. AFTER THEY CHANGED OUT THE BLANKET, THE BABY'S TEMPERATURE DECREASED, AND THEY WERE ASSUMING THE NEW PAD SEEMED TO BE WORKING CORRECTLY THEREAFTER. THEY DID KEEP THE PAD THAT THEY THOUGHT MAY HAVE BEEN LEAKING. SHOULD THEY CONNECT IT TO THE MACHINE TO SEE IF IT WAS IN FACT LEAKING. THEY WANT TO CHECK WHETHER THEY HAVE YOU HEARD OF THIS EVER HAPPENING BEFORE. THE SECOND ISSUE WAS ON (B)(6) 2025 AND THE NURSES WERE NOTING THAT THE BABY WAS READING COLD AND THE PAD WAS NOT GETTING WARMER. IT WAS STAYING AROUND 15-20 DEGREES DESPITE THE BABY HAVING AN ESOPHAGEAL TEMPERATURE OF 32.5-32.9 DEGREES. THE DID END UP CHANGING OUT THE PAD OVERNIGHT (ON 7/4) AND THE TEMPERATURE IN THE PAD DID INCREASE AND THE INFANT'S ESOPHAGEAL TEMPERATURE REMAINED WITHIN TARGET FOR THE REMAINDER OF THE THERAPY, BUT IT DID SEEM ODD. IT WAS REPORTED THAT THE COOLING STARTED AROUND 2PM YESTERDAY. THE NIGHT NURSE HAD TO REPLACE THE ARCTIC GEL PAD AROUND 2AM BECAUSE IT WAS WET. THEY DESCRIBED IT AS BUBBLING UP. WHEN THEY CAME ON AT 8AM, THE PAD WAS WET AGAIN. EXPLAINED THE WATER WAS UNDER A VACUUM MEANING THAT IF THERAPY WAS RUNNING AND WATER WAS CIRCULATING, THE WATER COULD NOT LEAK OUT, AIR GETS SUCKED IN. SUGGESTED LOOKING FOR ANOTHER SOURCE OF THE FLUID EXAMPLE URINE, IV FLUID. EXPLAINED THEY COULD PLACE THE PAD BEHIND THE NURSING STATION FOR QUALITY, IF DESIRED. ASKED TO TAKE PICTURES. THE PACKAGING HAS BEEN DISCARDED, NO LOT NUMBER AVAILABLE. CALLED BACK A FEW HOURS LATER AND THE NURSE CALLED LOCAL REPRESENTATIVE WHO TOLD HUP WAS EXPERIENCING THE SAME THING AND IT WAS BEING INVESTIGATED. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON (B)(6) 2025, SPOKE WITH NURSE WHO CONFIRMED THE PAD HAD BEEN LEAKING FLUID. THEY HAD SPOKEN WITH THEIR REPRESENTATIVE WHO CONFIRMED THIS SEEMS TO BE AN ONGOING ISSUE WITH PADS AND THOUGHT IT MIGHT BE DUE TO TRANSPORT IN A HOT VEHICLE BUT COULD NOT CONFIRM. THEY WOULD BE INVESTIGATING THIS. THE INFANT EXPERIENCED REDNESS ON THE SKIN THAT RESOLVED ON ITS OWN WITHOUT INTERVENTION. THERAPY WAS DISCONTINUED DUE TO PAD LEAKING. NO ALTERNATE FORMS OF TREATMENT WERE USED. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS REPORTED THAT THE INFANT WHO STARTED COOLING AT 1400 YESTERDAY, THIS MORNING AT 0200, THE BLANKET WAS SOAKED WITH WATER EXTERNALLY. IT WAS CHANGED, AT 0800 THIS MORNING, THE SAME THING HAPPENED. THE MALFUNCTION OCCURRED TWICE ON ONE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 533030 | ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS | NEONATAL ARCTIC GEL PADS | DWJ | MEDIVANCE, INC. ¿ 1725056 | UNK | 00801741132131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |