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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS; ARCTIC GEL PADS
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MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS; ARCTIC GEL PADS Back to Search Results
Catalog Number 317-07
Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)
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 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.
 
Event Description
It was reported that the device received a low flow alert.The patient began hypothermia mode on the first device and was transported to the icu.When they hooked the patient back up to the device, the low flow alert was noted.The nurse said she tried filling the device, however, it did not take up any fluid.Per troubleshooting, the complainant was advised that the pads must be disconnected to add water and the water level does not cause low flow.The patient¿s temperature was 36.5c with a target of 33c.The water temperature was 9c with a flow of 0 l/min.The complainant was advised to check the system diagnostics with the pads connected.The diagnostics read: flow rate (fr) 1.3l/min, inlet pressure (ip) - 0.8psi, circulation pump (cp) 100 %, and the conditioning valve 0.Pump hours were 1,025.The nurse disconnected and reconnected all of the pads and the flow rate remained 0 l/min.She did not want to do further troubleshooting and said she would obtain another device.A second call was received and the complainant reported that the device was working well until the patient went to ct.When they reconnected the patient to the device, the device received a patient line open alert.She stated that the flow started and then stopped.The event log showed that the device received an alert 01 and alert 02 multiple times.Per troubleshooting, the complainant found that the pads were bunched up under the patient¿s arms and around the chest and she was unable to reposition them.She could see no obvious signs of damage to the pads.The nurse confirmed that the fluid delivery line (fdl) was properly in place and instructed her to disconnect and reconnect the pads several times with no improvement.A second nurse confirmed that she could feel suction from the device when she removed the fdl.The pads were emptied and disconnected.The device was put in manual mode, but the patient coded before she could check the device.When another nurse called back, she tried reconnecting the pads.The flow rate would rise to 1.8-1.9l/min and then drop to 0l/min.She reported that the pads were a size m and were too small for the patient who weighed over 240lbs.She noted that some of the hydrogel on the pads were coming off.She was advised to change to size large pads and to return the size medium pads to field assurance.It was later reported that the nurse confirmed that once they switched to the larger pads, the patient was able to complete therapy successfully.She stated neither of the devices would be sent to the biomed.
 
Manufacturer Narrative
Received 1 articgel pad kit for evaluation.The reported event was confirmed.The pads were inspected and found to have the trim pattern correctly performed, the plastic tubes were found completely assembled covering the total of clamping rings on the plastic connector and manifold connector, the foams were found free of damages, tears or perforations, the seal between manifold connector and pad was found completely sealed, the energy connectors were found damaged for the right thigh pad and left thigh pad, it was noted that there was evidence of the sealing presence on the pads.No manufacturing issues related were noted during the visual evaluation of the pads returned.The pads were submitted to the flow rate test with the arctic sun machine model 2000.The pads were connected to the arctic sun machine model 2000 during 10 minutes, see details below: * right chest pad: a total of 5.09 l/min m2 of flow rate were registered during the test.* left chest pad: a total of 5.09 l/min m2 of flow rate were registered during the test.* right thigh pad: a total of 5.09 l/min m2 of flow rate were registered during the test.*left thigh pad: could not be stabilized due to the damaged connector according to the test method, the flow rate was found to be acceptable for the right thigh pad and right/left chest pads, the flow rate was found to be unacceptable for the left thigh pad.The flow rate for this product must be above 2.4 l/min m2.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: ¿5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.¿ ¿6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a full pad kit.¿.
 
Event Description
It was reported that the device received a low flow alert.The patient began hypothermia mode on the first device and was transported to the icu.When they hooked the patient back up to the device, the low flow alert was noted.The nurse said she tried filling the device, however, it did not take up any fluid.Per troubleshooting, the complainant was advised that the pads must be disconnected to add water and the water level does not cause low flow.The patient¿s temperature was 36.5c with a target of 33c.The water temperature was 9c with a flow of 0 l/min.The complainant was advised to check the system diagnostics with the pads connected.The diagnostics read: flow rate (fr) 1.3l/min, inlet pressure (ip) - 0.8psi, circulation pump (cp) 100 %, and the conditioning valve 0.Pump hours were 1,025.The nurse disconnected and reconnected all of the pads and the flow rate remained 0 l/min.She did not want to do further troubleshooting and said she would obtain another device.A second call was received and the complainant reported that the device was working well until the patient went to ct.When they reconnected the patient to the device, the device received a patient line open alert.She stated that the flow started and then stopped.The event log showed that the device received an alert 01 and alert 02 multiple times.Per troubleshooting, the complainant found that the pads were bunched up under the patient¿s arms and around the chest and she was unable to reposition them.She could see no obvious signs of damage to the pads.The nurse confirmed that the fluid delivery line (fdl) was properly in place and instructed her to disconnect and reconnect the pads several times with no improvement.A second nurse confirmed that she could feel suction from the device when she removed the fdl.The pads were emptied and disconnected.The device was put in manual mode, but the patient coded before she could check the device.When another nurse called back, she tried reconnecting the pads.The flow rate would rise to 1.8-1.9l/min and then drop to 0l/min.She reported that the pads were a size m and were too small for the patient who weighed over 240lbs.She noted that some of the hydrogel on the pads were coming off.She was advised to change to size large pads and to return the size medium pads to field assurance.It was later reported that the nurse confirmed that once they switched to the larger pads, the patient was able to complete therapy successfully.She stated neither of the devices would be sent to the biomed.
 
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Brand Name
ARTICGEL PADS
Type of Device
ARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key7224936
MDR Text Key98975802
Report Number1018233-2018-00248
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number317-07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2018
Date Manufacturer Received04/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight109
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