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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS; ARCTICSUN GEL PAD
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MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS; ARCTICSUN GEL PAD Back to Search Results
Catalog Number 318-01
Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the device was alarming low flow.The patient's temperature was down to 29c range with a target 37c.Ms&s confirmed that a pediatric pad was in use, the flow rate was 0.4 l/min.Per troubleshooting, the pads were disconnected and reconnected using proper technique, flow did not improve.The nurse noted that a small universal pad was in use and not a pediatric pad.A call was received from the facility, while in normothermia mode, and the device's water temperature was not increasing.The target temperature was 37c, the patient temperature was 33c, and the water temperature was 10c.The nurse turned the machine off and then called the arcticsun helpline.Prior to troubleshooting, ms&s had the nurse turn the device back on, the water temperature was 36.8, the patient temperature was 36.8c, and the flow rate was 1.7 l/min.It was explained that 1 small universal pad was not adequate for 11 kg.The nurse stated that additional pads were going to be added.She stated no alarms or alerts have gone off.Testing for brain activity was scheduled for later that day.A call was received from the facility stating that the facility did not have any more small universal pads and an xxs small kit was used.The flow rate was optimal, the patient's temperature was 35.8c, and the water temperature was 40c.An additional call was received from the facility, the patient was set to warm to 37c under normothermia an hour later stating that the water temperature was 10c, and the patient temperature was fluctuating from 37c to 35c.Ms&s had the nurse adjust the rewarm settings to 0.25/hr and adjust the max water temperature.The water immediately increased to 30c.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿the arcticgel¿ small universal pads are only for use with the arctic sun® temperature management system.See operators manual for detailed instructions on system use.¿ select the proper number of pads for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the maximum number of pads.¿ the following sizing chart is provided as guidance.Modify the number of pads and locations as necessary to meet specific clinical needs.¿ place the pads on healthy, clean skin only.Locate pad edges away from articulating areas of the body to avoid irritation.Place pads to allow for full respiratory excursion.¿ the pad surface must be contacting the skin for optimal energy transfer efficiency.The small universal pads are provided with a cloth liner over the hydrogel.The pads may be used with the cloth liner in place or removed to expose the hydrogel adhesive.If the cloth liner is used, secure the pads with the velcro straps to ensure good contact with the skin.The pads may be removed and reapplied if necessary.¿ due to the small patient size and the potential for rapid patient temperature change ¿ 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 ¿ it is recommended to use the patient temperature high and patient temperature low alert settings.¿ place a core patient temperature probe and connect to the arctic sun® temperature management system patient temperature 1 connector for continuous patient temperature feedback.A rectal or esophageal temperature probe is recommended.¿ attach the pad¿s line connectors to the fluid delivery line manifolds.Begin treating the patient.¿ if the pads fail to prime or a significant continuous air leak si observed in the pad return line, check connections, then if needed replace the leaking pad.¿ once all the pads are primed, assure the steady state flow rate displayed on the control panel is appropriate for the number of pads connected." section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported that the device was alarming low flow.The patient's temperature was down to 29c range with a target 37c.Ms&s confirmed that a pediatric pad was in use, the flow rate was 0.4 l/min.Per troubleshooting, the pads were disconnected and reconnected using proper technique, flow did not improve.The nurse noted that a small universal pad was in use and not a pediatric pad.A call was received from the facility, while in normothermia mode, and the device's water temperature was not increasing.The target temperature was 37c, the patient temperature was 33c, and the water temperature was 10c.The nurse turned the machine off and then called the arcticsun helpline.Prior to troubleshooting, ms&s had the nurse turn the device back on, the water temperature was 36.8, the patient temperature was 36.8c, and the flow rate was 1.7 l/min.It was explained that 1 small universal pad was not adequate for 11 kg.The nurse stated that additional pads were going to be added.She stated no alarms or alerts have gone off.Testing for brain activity was scheduled for later that day.A call was received from the facility stating that the facility did not have any more small universal pads and an xxs small kit was used.The flow rate was optimal, the patient's temperature was 35.8c, and the water temperature was 40c.An additional call was received from the facility, the patient was set to warm to 37c under normothermia an hour later stating that the water temperature was 10c, and the patient temperature was fluctuating from 37c to 35c.Ms&s had the nurse adjust the rewarm settings to 0.25/hr and adjust the max water temperature.The water immediately increased to 30c.
 
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Brand Name
ARTICGEL PADS
Type of Device
ARCTICSUN GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key8005593
MDR Text Key125298774
Report Number1018233-2018-04988
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 02/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number318-01
Was Device Available for Evaluation? No
Date Returned to Manufacturer10/09/2018
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight11
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